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HIV VACCINE ETHICS COMMITTEE REPORT

 HIV VACCINE ETHICS COMMITTEE REPORT

BACKGROUND

TERMS OF REFERENCE OF HIV VACCINE ETHICS COMMITTEE

The Government of Trinidad and Tobago appointed an HIV Vaccine Ethics Committee on the 19th March 1998 with the following Terms of Reference:

(a)                To become acquainted with the technical aspects of HIV Vaccine Programmes including their methodologies;

(b)               To assess the suitability of HIV/AIDS Vaccine Programmes that request trials in Trinidad and Tobago;

(c)                To make recommendations to the Minister of Health with respect to proposals for HIV vaccine trials. If it is agreed to conduct vaccine trials in Trinidad and Tobago:

(d)               To ensure that the standards of the vaccines meet well established and acceptable world standards;

(e)                To ensure that the persons for whom the vaccines are intended are not exposed to undue health risks;

(f)                 To ensure that the technologies used for conducting the trial are all safe and ethical;

(g)                To monitor the activities of HIV vaccine trials.

 

MEMBERSHIP OF VACCINE ETHICS COMMITTEE:

The Committee initially comprised the following:-

      Dr. Rawle Edwards      -      Ag. Chief Medical Officer, Chairman

      Dr. Edward Addo      -      Medical Practitioner (Specialist Treating HIV/AIDS patients)

      Fr. Clyde Harvey      -      Priest - Roman Catholic Church

      Pastor Clive Dottin      -      Pastor - Seventh Day Adventist Church

      Mr. Paul Ellis      -      Representative of Pan American Health Organization/ World Health Organisation (PAHO/WHO )

      Dr. Roderick Doug-Deen      -      Retired Chief Medical Officer

      Dr. Waveney Charles      -      Director, National Blood Transfusion Service

      Professor Rolf Richards      -      Emeritus Professor of Medicine, UWI

      Professor Ramesh Deosaran      -      Head, Department of Behavioural Science,      UWI

      Ms. Eunice Gittens      -      Representative - Ministry of Social and Community Development

      Dr. Hari Maharaj      -      Representative - Trinidad and Tobago Medical Association

      Mr. Joe George      -      Representative - National Trade Union Centre      (NATUC)

      Mrs. Agatha Carrington      -      Representative - Tobago House of Assembly

 

During the life of the Committee, it was noted that the input of a lawyer was required.  In addition, there were some members who could no longer attend, either due to death, or migration.  As a result the Committee was reconstituted by Cabinet on 15th March 2000 and comprised the following:

      Dr. Rawle Edwards      -      Ag. Chief Medical Officer (Chairman)

      Dr. Michelle Monteil      -      Senior Lecturer in Immunology, FMS, UWI (to replace Dr. Edward Addo - deceased)

      Fr. Clyde Harvey      -      Priest - Roman Catholic Church

      Pastor Clive Dottin      -      Pastor - Seventh Day Adventist Church

      Dr. Claudette Harry -      Representative of Pan American Health Organisation/World Health Organisation (PAHO/WHO) (to replace Mr. Paul Ellis - migrated)

      Dr. Roderick Doug-Deen      -      Retired Chief Medical Officer

      Dr. Waveney Charles      -      Director, National Blood Transfusion Service

      Professor Rolf Richards      -      Former Professor of Medicine, UWI

      Professor Ramesh Deosaran      -      Head of Department of Behavioural Science UWI

      Ms. Eunice Gittens      -      Representative - Ministry of Social and Community Development

      Dr. Hari Maharaj      -      Representative - Trinidad and Tobago Medical Association

      Mr. Joe George      -      Representative - National Trade Union Centre      NATUC

      Mrs. Agatha Carrington      -      Representative - Tobago House of Assembly

      Mrs. Lynette Seebaran-Suite                -      Attorney-at-Law (to be appointed to the Committee)

The Committee was well aware of its challenges, and held regular meetings.  The meetings were designed to have members acquaint themselves with the range of ethical issues that can arise in adjudging AIDS vaccine trials in Trinidad and Tobago.

When the Committee first met, Trinidad and Tobago was being considered for HIV vaccine trials, but no protocol for trials was at that time submitted, ready or available.

UNAIDS ASSESSES TRINIDAD AS A SITE FOR HIV VACCINE TRIALS

In December 1997, the Executive Director of UNAIDS, Dr. Peter Piot, wrote the Honourable Minister of Health indicating that "UNAIDS is presently exploring the possibilities of supporting selected HIV vaccine evaluation sites in the Caribbean.  The criteria for selection are based on the willingness and commitment of the Government, the epidemiological data, the existence of appropriate laboratory, clinical and data management infrastructures supported by trained professionals in each of the areas.

Based on these criteria, he is of the view that Trinidad and Tobago is in a good position to develop a site for HIV vaccine development and evaluation.  Thus, he would like to initiate discussions on possible collaboration between UNAIDS and Trinidad and Tobago, to explore the possibilities for future HIV vaccine activities."

Following this communication, a team from UNAIDS visited Trinidad in March 1998 and among other activities held a meeting with the members of the Vaccine Ethics Committee.  One of the outcomes of this meeting was an undertaking from UNAIDS to assist the Vaccine Trial Committee in its work.

VACCINE ETHICS COMMITTEE PREPARES TO RECEIVE A PROTOCOL FOR HIV VACCINE TRIALS

The Vaccine Committee initially set about familiarising itself with its Terms of Reference, and collecting the literature and data necessary  to guide it in its future work.  The cornerstone of the documents considered essential to the work of the Committee was:

(a)      International Ethical Guidelines for Biomedical       -      See Annex 1

      Research Involving Human Subjects

Additionally, Dr. Rawle Edwards, Chairman of the Committee, attended a two-day conference at the headquarters of UNAIDS on the 25th and 26th June 1998.  The draft "Guidance Document on Ethical Considerations in HIV Vaccine Trials" was discussed by approximately 50 participants from all over the world, including some well-known ethicists from the USA and Europe.

Dr. Hari Maharaj and Dr. Waveney Charles attended a training workshop in Research Ethics in Geneva, Switzerland, held on the 25-26th March 1999.

Further preparation included the mounting of a workshop in Trinidad and Tobago on Friday 29th January 1999.  The objectives of the workshop were:

1.                  To acquaint and update members on ethical issues involved in HIV vaccine trials.

2.                  To devise a framework of approach with respect to future submissions of protocols for vaccine trials.

Presentations at the workshop were made by:

Dr. Saladin Osmanov                 - Present Status of HIV Vaccine Evaluation:  A Global Perspective Member,  UNAIDS Vaccine Team     

Dr. David Picou                    -  Research Issues concerning HIV/AIDS Vaccine Trials:  A Caribbean Perspective, Director, Caribbean Health Research Council                

Dr. Ruth Macklin       -  UNAIDS process to Develop Guidance on the Ethical Conduct of International Trials of Preventive HIV Vaccines, Chair,      UNAIDS Ethical Review Committee     

Dr. Ruth Macklin        -  Development of a Strategic Framework to guide the  National HIV Vaccine Committee

The major issues which were raised and debated at the workshop were:

1.    The suitability of the Caribbean as a site for HIV vaccine trials and information required to run them.

2.    The role of the ethical review committee in Trinidad and Tobago.

3.    The role of the media and the Community Advisory Board (CAB)

4.    The role of UNAIDS in HIV vaccine trials

The full report on the workshop is presented as Annex 2.

A sub-committee was appointed to prepare a detailed plan of action to assess any proposal for HIV vaccine trial submitted to the Committee.

The sub-committee comprised the following:

      Dr. Hari Maharaj - Chairman

      Pastor Clive Dottin

      Mrs. Agatha Carrington

      Professor Rolf Richards

The sub-committee's plan was tabled at a meeting held on 27th August 1999, when it was submitted to the rest of the committee.  The report is affixed as Annex No. 3.

Through the Honourable Minister of Health the Committee received an application for the conduct of an HIV Vaccine trial in Trinidad and Tobago, from the Medical Research Foundation of Trinidad and Tobago (MRFTT).  The application letter, dated 29th July 1999, was received by the Committee on the 6th August 1999.

The application was submitted in two parts.  The first was entitled "HIVNET Protocol 026 Ñ Informed Consent and Questionnaires for Screening and Enrolment of Volunteers for proposed Vaccine Trials in Brazil, Haiti and Trinidad and Tobago," and tabled at the meeting held on the 27th August 1999.

The second part of the protocol entitled "HIVNET Protocol 026 Ñ A multi-site Phase II Clinical Trial to evaluate the Immunogenecity and Safety of ALVAC HIVvcp1452 Alone and Combined with MN rgp 120 in Brazil, Haiti and Trinidad and Tobago", was received on the 19th September 1999.

The Director of the MRFTT, in his application letter of the 29th July 1999, indicated that the enclosure contains "HIVNET Protocol 026 Ñ Informed Consent and Questionnaires for Screening and Enrolment of Volunteers for proposed Vaccine Trials in Brazil, Haiti, and Trinidad and Tobago are the three countries in this hemisphere which were selected by HIVNET as capable of conducting vaccine trials in concert with similar trials in the USA and France.  The scientific details of the proposed ALVAC vaccine, on the other hand, will follow, but at least not before the end of September 1999."

The clinical trial is sponsored by the National Institute of Allergy and Infectious Diseases, (NIAID), the Division of AIDS (DAIDS), Vaccine and Prevention Research Programme, Clinical Development Branch, Bethesda, Maryland.  The contact list of participants was submitted with the protocol. Vaccines are provided by Pasteur Merieux Connaught VaxGen, Inc.

The HIV Network for Prevention Trials (HIVNET) was established in 1993 by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID).  Its goal is to conduct domestic and international multi-centre trials to evaluate the safety and efficacy of promising interventions to prevent sexual, perinatal, and parenteral transmission using HIV seroincidence as the primary trial endpoint.  The interventions to be evaluated encompass various treatment and reduction strategies and include the evaluation of vaccines.  The HIVNET Protocol 0206 is being carried out to evaluate a vaccine provided by Pasteur Merieux Connaught VaxGen Inc.  This is a multiple site Phase II clinical trial to evaluate the immunogenicity and safety of ALVAC-HIV vCP1452 alone and combined with MN rgp 120 in Brazil, Haiti and Trinidad and Tobago.  The Medical Research Foundation is one of the 16 participants in the HIV NET Protocol 026.

VACCINE ETHICS COMMITTEE EVALUATES HIVNET PROTOCOL 026

The committee began evaluating the first part of the protocol which was received in August 1999.  This part of the proposal is directed mainly to the recruitment of volunteers and conditionalities governing their participation in the trial.

Soon after receiving the second and more technical part of the proposal, the committee invited Dr. Barbara Hull[1][1] to one of its regular meetings in order for members to familiarise themselves with the technical and scientific detail of the vaccine, and the potential effects that it may have on human health.

The information provided by Dr. Hull was later corroborated by Dr. Michelle Monteil when she became a member of the Vaccine Ethics Committee, and whose paper dated May 2, 2000 adequately translates the technical information about the vaccine into simple language for the layman.  See Annex No. 4.

After several meetings debating the issues thoroughly among its membership, the Committee crystallised the major areas of concern by developing a list of critical questions.  See Annex 5.  These questions were further subdivided into three categories based on where the answers were to be derived. These answers were to be derived from the following:-

(a)                from within the Committee

(b)               from among selected experts

(c)                from the researchers (MRFTT).

See Annex 6

Pursuant to this strategy, the Committee's questions to the researchers were addressed to the MRFTT.  See letter at Annex 7.

The responses from the MRF and researchers were received both in writing - See Annex 8 - and through their personal appearance before the Committee, to clarify other lingering questions in the minds of many members of the Committee.  The minutes of that meeting are attached - Annex 9.

In response to the questions concerning the experiences of the evaluation of the trial protocol in Brazil and Haiti, through PAHO, responses received are annexed at 10a and 10b. A report prepared by Professor Rolf Richards outlining the known human complications of previous trials using similar vaccines is given in Annex 11.

Committee Findings and View:

1.      INTRODUCTION TO THE STUDY

      The proposal entitled "HIVNET PROTOCOL 026 - A multi-site Phase II clinical trial to evaluate the immunogenicity and safety of ALVAC-HIV VCP1452 and combined with MN rgp 120 in Brazil, Haiti and Trinidad & Tobago" was submitted to the Cabinet-appointed HIV Ethics Committee for scrutiny in September 1999. The document provided details of a proposed trial in Trinidad, of a novel vaccine called ALVAC-HIV vCP1452 alone or in combination with another vaccine, MN rgp 120.  Since this study was also to be undertaken in Haiti and Brazil, the proposal has also been submitted to and accepted by Ethics Committees in these two countries.

      The protocol has been studied and discussed extensively by members of the Cabinet-appointed Ethics Committee. The ensuing will attempt to summarize key points in the proposal document (HIVNET PROTOCOL 026) in simple, non-technical language, as far as possible. Additionally, concerns raised by Committee members will be listed and recommendations, aimed at addressing these concerns, will be provided.

2.  PURPOSE OF STUDY

      In this proposed clinical trial, healthy, non-HIV infected adult volunteers at low risk of HIV infection will be administered multiple doses of one (ALVAC-HIV) or both (ALVAC-HIV & MN rgp120) HIV vaccines. 

The aim of the study is three-fold,

1)      To gather further data on the safety of these vaccines,

2)      To determine the ability of these  experimental vaccines to generate protective anti-HIV immune responses in volunteers, and

3)      To establish whether Trinidad could be used as a future site for larger scale vaccine trials with these or other HIV vaccines.

The reasons cited for conducting the trial in Trinidad, Brazil and Haiti are as follows,

i.        Since the quality of immune response to some vaccines can be affected by factors such as race and nutritional status, the vaccine is being given to volunteers in different racial groups and from both developed and lesser-developed countries,

(The researchers argue that it is important to characterise immune responses to the vaccines in as many different populations as possible since this will assist in ultimately determining whether or not these vaccines can be effective in a global context)

ii. "The initiation of vaccine trials in developing countries is indicated because of the high risk and tremendous impact of HIV-1 infection in those settings"

iii.            The HIV-1B subgroup virus causes HIV infection in Caribbean countries.  The vaccine to be studied is based on this HIV subtype so that countries in the Caribbean and Brazil are particularly appropriate for studies with this vaccine. The HIV-1B subgroup virus is also the cause of most infection in the United States of America.

3.   BACKGROUND

Different HIV vaccine candidates have been undergoing clinical trials for over 10 years. None of these has produced all the elements of what scientists think constitute HIV-specific protective responses.  Hence, new and combined preparations are being developed and tested.

The proposed vaccine trial in Trinidad will use a comparatively new preparation: ALVAC vCP 1452 (Vaccine A) alone and in combination with a well-tried preparation, MN rgp 120 (Vaccine B).  It is hoped that this approach will produce good protective immunity in volunteers. Good protection consists of HIV-specific killing cells and antibodies.

4.    VACCINE PRODUCT DESCRIPTIONS

            The ALVAC-HIV VCP1452 (Vaccine A) vaccine is a genetically engineered vaccine consisting of,

(a)      (i)  CANARY POX VIRUS - a virus that causes pox in birds but which does not cause disease in humans,

(ii)           HIV-1 GENES - some (but not all) of the genetic material from the HIV virus.

(iii)           VACCINIA (COWPOX) GENES - bits of genetic information from the cowpox virus that enhance the production of proteins made from the HIV genes.

(b)   The HIV-1 MN rgp 120  (Vaccine B) vaccine is a genetically engineered vaccine consisting of parts of the HIV coating (envelope) that is important for the virus to gain entry into human cells.

      The ALVAC-HIV vaccine (Vaccine A) works in the following way:

The Canary Pox virus is filled with HIV genes. This virus can enter a wide variety of human cells and at the site of inoculation will enter muscle and other local cells.  Inside these cells it uses the protein making machinery of the human cells to make proteins from the HIV genes. These HIV proteins are exported from the human cell and will be seen by the immune system.  The immune system will in turn make a protective response. In essence the immune system is shown the important bits of the HIV virus without encountering the "real" HIV organism.  In particular, this vaccine stimulates a CELL-MEDIATED IMMUNE RESPONSE i.e. the production of HIV-specific killing cells.

      Vaccine B, the MN rgp 120, stimulates the production of HIV-specific antibodies.  These antibodies, called neutralising antibodies, inhibit the entry of the HIV virus into human cells and thus prevent infection.

Safety Data on ALVAC vCP 1452

The Ethics Committee is aware of safety data on the use of Vaccine A (ALVAC vCP 1452) in 85 people (77 HIV-uninfected adult volunteers & 3 HIV-infected individuals. Generally, this vaccine was well tolerated with "more moderate* or severe# local symptoms when compared with other" vaccines of this type.  There were no severe generalised (systemic) reactions

*Moderate Local Symptoms = notable pain or tenderness at site of inoculation; some limitation of use of arm

#Severe Local Symptoms = extreme pain or tenderness; complete limitation of use of arm

Safety Data on MN rgp 120

The proposal reported that Vaccine B (MN rgp 120) "has been given to over 1,300 individuals for prophylactic and therapeutic indications in the U.S. and Thailand".

The vaccine was well tolerated with no severe adverse reactions. The commonest complaints were redness and swelling at injection sites.

5.  STUDY DESIGN

It is proposed that forty (40) non-HIV infected, healthy adult volunteers will be recruited in Trinidad and Tobago. These individuals will be assigned randomly to one of three groups as follows;

Group A Ñ 15 persons will receive 4 doses of Vaccine A (ALVAC vCP 1452) and 2 doses of Vaccine B (MN rgp 120).  Vaccines A&B will be given together on 2 occasions. Each individual will receive a total of 4 injections over a 6-month period.

Group B Ñ 15 persons will receive 4 doses of Vaccine A alone as 4 injections over 6 months

Group C Ñ 10 persons will receive no vaccine. They will receive a placebo. These volunteers constitute the "CONTROL" group

SELECTION OF SUBJECTS

Vaccine volunteers, as stated in the proposal, "will be healthy HIV-1 uninfected adults who fully comprehend the purpose and details of the study and are carefully screened to be at lower risk of acquiring HIV infection."

SCREENING

This is intended to be "a multi-step process" that will ensure that vaccine volunteers are healthy, uninfected with HIV and of lower behavioural risk for acquiring the disease. This will consist of "an interviewer-administered behavioural eligibility checklist, a physical examination, specimen collection, HIV testing and related counselling".

Additionally, as stated in the proposal "all volunteers will receive detailed information about the study, will have any questions answered by trained study staff and will be allowed time to carefully consider their decision about participation". As far as we are aware, personnel of the Medical Research Foundation will perform all aforementioned tasks.

An assessment of an individual's understanding of the study details will be determined by completion of a self-administered questionnaire. All questions will have to be answered correctly before the volunteer will be allowed to sign the study consent form.

Dr. Farley Cleghorn, co-investigator of this project, told the Ethics Committee that the project investigators have estimated that approximately 600 volunteers will have to be screened in order to identify 40 volunteers for the vaccine trial. Potential volunteers will be provided with US$15 per visit to assist in covering transport costs and income from loss of work.

SAFETY MONITORING

Vaccine safety will be assessed by monitoring of volunteers for generalised and local reactions.  This will consist of clinical and laboratory testing and this will occur immediately after each immunisation and for a minimum of 18 months after the first administration of vaccine to each volunteer.

The proposal states that the progress of the trial will be monitored by a group of experts known as the "The Division of AIDS (DAIDS) Vaccine and Prevention Data and Safety Monitoring Board" which, will include ad hoc representation from Trinidad.

Studies to be Performed

The studies to be performed following each administration of vaccine will consist of the following:

a)      Tests to assess safety: measurement of hematological and biochemical parameters

b)      Tests to assess immune response to HIV:

ü      Antibody response to HIV-1 (quantitative & qualitative responses)

ü      Cellular immune response to HIV-1 (quantitative & qualitative responses).

c)      Tests for the presence of HIV infection: Molecular biological methods (RNA PCR assay) will be used to assess all volunteers at the start of the trial for the presence of HIV infection.

Major Concerns

(1)               Is the vaccine likely to cause AIDS?

Response

No  - Highly unlikely.  The scientific data made available is that this is highly unlikely.

This conclusion is based on the use of the vaccine in the USA and France,  and on the theoretical underpinnings of the design of the vaccine which is based on well proven scientific principles.

There is concern that altering the genetic composition of the Canary Pox may also alter its ability to mutate and cause infection in man. The likelihood is unknown but previous research suggests that this is unlikely.

(2)   Will the vaccine make those who receive it HIV positive?

Response

Yes.  Immunisation with these vaccines will result in HIV antibody positivity.  This can have adverse consequences for volunteers socially especially if they wish to migrate or get life insurance.  It also has implications for their personal relationship(s) and even on the job, or for their career.

However the MRFTT has access to biochemical tests which will differentiate between vaccine-produced positivity and native- infected positivity.

(3)   What are the known side effects of the vaccine and are they a threat to human life and limb?

Response

Only "local reactions" to vaccination have been reported to date.  Local reactions are transient and include slight swelling, mild redness and maybe some pain confined to the site of the inoculation.  See Annex 11 for details.

(4)         The proposal did not state explicitly how potential volunteers would be identified.

Response

It should be ensured that individuals are not volunteering for the trials because they are in some way dependent on the MRFTT.  An independent assessor, on behalf of the Government of Trinidad and Tobago (GOTT) should interview potential volunteers to determine any possible financial or other dependency on the MRFTT.  Invitation to participate in the trials should be general, indicating the profile of the volunteer required, and not target any particular group.

(5)        The manner proposed to recruit volunteers - Is it  ethical?

(i)   What about the stipend offered, is it a reward, or inducement?

(ii)  Is the stipend sufficient?

Response

"The clinic visits and laboratory tests associated with the screening will be provided free of charge.  The volunteers will have to pay for any medical costs not directly related to the screening.  They will be compensated for each scheduled visit they attend during the screening.  Volunteers will receive reimbursement only for meals, transportation and time away from work - approximately TT$100.00 (US$15.00), because an unduly large stipend may provide an incentive."

(i)   The amount of money offered is NOT an inducement, and is not seen in itself as rewarding for participants.

 

(ii)  Especially for those who lose time on the job or have to travel long distances, the quantum is NOT sufficient.  Special consideration must be given to volunteers who travel long distances e.g., Moruga, Toco, Tobago

(6)   What happens if someone gets HIV infection as a result of his or her own risk behaviour and in spite of adequate counselling?

Response

Counselling provided within the screening process (as informed through the protocol) will guide volunteers into understanding their responsibility in sexual behaviours.  However, experience has shown that recruits in other study sites have engaged in risky behaviour despite adequate counselling.  The Committee was divided as to the responsibility of researchers, in the event that volunteers contracted HIV as a result of their risk behaviour.

(7)   What happens in the unlikely event that someone gets HIV Infection from the vaccine?

Response

The Committee was unanimous in proposing that the best treatment available in the world should be afforded the volunteer, at the cost to the researchers.

(8)   What happens after the trial is completed in 18 months?

Response

The MRFTT is to make access to medical information of volunteers available to the Chief Medical Officer, and to their personal physician (with the volunteer's consent) in the event that they develop medical problems long after the trial was completed.  This will allow for accurate assessment of the problem at the time.

(9)   Who supervises the ethical conduct of the trial?

Response

(1)   The DAIDS Vaccine and Prevention Data and Safety Monitoring Board (VPDSMB), with ad hoc representation from Brazil, Haiti, and Trinidad and Tobago, will monitor the progress of the trial. 

(2)   The Government of Trinidad and Tobago HIV/AIDS Vaccine Trial Ethics Committee.

(10) Have similar studies been carried out before?  If yes, where?

Response

The gp 120 candidate vaccine has been given to at least 7,000 volunteers for the last 9 years, including 5,400 volunteers participating in a Phase III trial in the USA.  A similar candidate vaccine is being tested in Thailand.

Canary Pox-HIV vectored vaccines have been tested on approximately 1,000 volunteers, mainly in the USA and France.  A Phase I/II trial started in Uganda.

(11) The informed consent documents, while quite comprehensive, will require good reading and comprehension skills in order to be fully understood.  The use of videos and further explanations to reinforce the written word will be available but only through project personnel.  How impartial will this process be?

Response

There should be a government-appointed assessor involved in all aspects of the informed consent process.  This assessor will ensure that each volunteer has obtained relevant information in an impartial manner and that he or she fully understands the information given in the informed consent documents.

HIV/AIDS GLOBAL ANALYSIS (UNAIDS)

Adults and children living with HIV/AIDS       -  total:   34.3 million.

People newly infected with HIV in 1999

TOTAL 5.4 million

Adults 4.7 million

Women 2.3 million

Children < 15 years 620 000

Number of people living with HIV/AIDS

Total 34.3 million

Adults 33.0 million

Women 15.7 million

Children < 15 years 1.3 million

AIDS deaths in 1999

Total 2.8 million

Adults 2.3 million

Women 1.2 million

Children < 15 years 500 000

Total number of AIDS deaths since the beginning of the epidemic

Total 18.8 million

Adults 15.0 million

Women 7.7 million

Children < 15 years 3.8 million

Total number of AIDS orphans since the beginning of the epidemic 13.2 million

 

HIV/AIDS TRINIDAD AND TOBAGO ANALYSIS

The first AIDS cases in Trinidad and Tobago were reported to the Ministry of Health in 1983.  These cases were all male adults.  In 1985, the first adult female and paediatric cases were reported.

Since the start of the Trinidad and Tobago epidemic, infection by sexual exposure has been the main mode of transmission.  Male to male sexual transmission first dominated the epidemic but by 1990 male to female sexual transmission accounted for the majority.

The reported number of cases of HIV has risen dramatically since the first few cases were identified in 1983.

Figures below reflect the number of new cases reported per year.

1985              -      112

1988              -      242

1992              -      484

1996              -      846

1999              -      1,179

For the period under review a total of 8,163 cases were reported, 4,983(61%) were males and 2,826 (35%) females.

The first child born with HIV was reported in 1985.  Paediatric cases (that is, children under 13 years) now represent 7% of all reported HIV infection; 7.5% of reported AIDS cases and 6% of AIDS deaths.

WORLD HIV CONFERENCE, 2000

The world turned its attention to the problem of HIV infection and AIDS during the week beginning July 7th, 2000.  From the point of view of advocacy, the meeting in Durban, South Africa was a resounding success.    President Mandela indicated that AIDS was responsible for more deaths in Africa than all the previous wars - the enormity of the tragedy of this epidemic can be counted not only by lives lost, but by economic retardation and destruction, dislocation of entire communities if they continue to exist, loss of longevity, orphaning of a significant part of an entire generation, social immobilisation and the massive redirection of human energy to consoling and caring for human beings who will not live much longer.

Trinidad and Tobago, like the rest of the world, developed and developing, will NOT escape the ravages of this epidemic unless a cure is found.  As a matter of principle, whenever and wherever possible, every opportunity must be given to the control of this disease.  It is in the context of this harsh reality, added of course to the cold calculated assessment of the vaccination protocol and assessment of the accuracy of the science, that the Committee conducted its deliberations.

SUMMARY AND RECOMMENDATIONS

The majority of the Committee recommends the approval of the vaccine for use as set out in Protocol 026.

The committee recommends that this approval be subject to the following conditions:-

(1)               The Government of Trinidad and Tobago reserves the right to stop the vaccine trials in the event of any unforeseen circumstances that are highly disadvantageous or inimical to the health or well being of the volunteers or the larger society.

(2)               The Government of Trinidad and Tobago develops a policy, and takes whatever steps are necessary, to protect the volunteers who become HIV positive from vaccine administration against any form of discrimination (e.g. in the workplace, application for life insurance etc.) because of this HIV positivity.

(3)               The Government of Trinidad and Tobago must provide a full-time, well-experienced counsellor to observe that the selection and counselling of volunteers is carried out in an acceptable manner and in keeping with the well known tradition of science.

(4)               The Medical Research Foundation of Trinidad and Tobago provides, free of cost to the patient, the best current available treatment/management in the world for the remainder of his or her life should any volunteer develop HIV infection as a result of the vaccine.

(5)               The Government of Trinidad and Tobago ensures that the Medical Research Foundation of Trinidad and Tobago and their international collaborators provide FREE OF CHARGE to all trial participants, for up to 5 years after the cessation of the trial, the biochemical test that distinguishes vaccine-induced versus natural infection-induced seroconversion.

(6)               The Medical Research Foundation of Trinidad and Tobago must turn over all clinical information to the Chief Medical Officer at the end of the trial or during the trial should a volunteer appear for medical treatment at a public or private health institution.

(7)               The Government of Trinidad and Tobago is to develop a communication strategy in order to inform and educate the public with respect to available information on the HIV vaccine trial in Trinidad and Tobago.

(8)               The Government of Trinidad and Tobago seeks to get full assurance from other Governments, especially that of the United States of America, that those persons who become HIV positive because of the vaccination be treated with equality when applying for visas or wanting to migrate.

(9)               The Government of Trinidad and Tobago lobbies the United Nations to develop an international treaty whereby all Governments will ensure that the vaccine is made available at a reasonable price to all citizens in the event that an effective vaccine is developed, and given the universally deleterious effects of AIDS.

(10)           The Division of AIDS, National Institute of Allergies and Infectious Diseases, United States National Institute of Health have a strict requirement to assure appropriate monitoring of vaccine trial results as they emerge, so that volunteers can be confident that attention is paid to their safety and other human subject protections.

The Department of Health and Human Services is arranging for host countries like Trinidad and Tobago, Haiti and Brazil to participate in the Data and Safety Monitoring Board (DSMB).

The Government of Trinidad and Tobago should participate in this activity, and the Committee wishes to recommend one of its members, Dr. Michelle Monteil for consideration to represent the country at those meetings.

NIAID funds will cover the expenses of the participation by a representative of Trinidad and Tobago.

See letter of invitation      -      Annex No. 12A

See response to invitation      -      Annex No. 12B

Permission granted for the conduct of this Phase II trial does not imply automatic permission for a Phase III or other trials.  Permission for a Phase III or other trials MUST be subjected to the same analysis and process as the Phase II trial.

 

[1][1] Dr. Barbara Hull is a trained virologist who worked initially with the Trinidad Regional Virus Laboratory.   Her next assignment was again Virologist and Head of Laboratory Services at the Caribbean Epidemiology Centre (CAREC).  In 1992 she was recruited as a virologist for the World Health Organisation Polio Eradication Team.  She retired in 1998.

Her work as a virologist is respected, as she was the first person to demonstrate that rotaviruses infection is a major cause of gastroenteritis in children.  This discovery brought about new approaches to the clinical management of gastroenteritis as well as to a mother-targeted public education programme.  Her finding contributed significantly to a decrease in mortality from gastroenteritis in children.

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