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close this bookUNAIDS-Sponsored Regional Workshops to Discuss Ethical Issues in Preventive HIV Vaccine Trials (UNAIDS, 2000, 52 p.)
close this folderWORKSHOP REPORTS
close this folderENTEBBE, UGANDA, 27-29 APRIL, 1998
View the document1. Phase I/II (Safety and Immunogenicity) Trials
View the document2. Phase III Trials
View the document3. Vulnerability to Harm and Exploitation
View the document4. Community
View the document5. Ethical Review
View the document6. Intellectual Property
View the document7. Control Arm in Trials
View the document8. Informed Consent
View the document9. Counselling
View the document10. Gender, Pregnancy and Breast-Feeding
View the document11. Children
View the document12. Discrimination
View the document13. Treatment and Care
View the document14. Endpoints in Vaccine Trials
View the document15. Compensation for Injury or Harm
View the document16. Access and Availability of Vaccine

7. Control Arm in Trials

Consensus:

Any preventive HIV vaccine trial must include risk behaviour counselling and provision of condoms for all participants, as this is currently the only known effective prevention intervention. It is scientifically preferable, and ethically acceptable, to use an inactive substance as a control for the vaccine, as long as there is no other effective HIV vaccine available.

Discussion:

A question was raised concerning what should be included in the control arm if a vaccine proven to be marginally effective against HIV was available. There was limited discussion on this, but some were of the opinion that the proven vaccine should be used regardless of level of effectiveness.

Controversy:

The group was divided on whether it was ethically acceptable to provide no benefit beyond counselling to those in a control arm, and some felt that it would be preferable to administer a vaccine with proven effectiveness against another disease, such as hepatitis B. It was pointed out that this may need to be viewed as an additional vaccine trial for hepatitis B (with the control arm for the hepatitis B trial being the candidate HIV vaccine arm), and that appropriate analysis would need to be carried out. The opposing point of view was that it would not be ethical to provide a beneficial vaccine to those in a control arm while there is no proven beneficial substance being given to those in the treatment arm.

A suggestion was to consider having three arms in the trial, one using candidate HIV vaccine, one with inactive substance, and one with a public health vaccine such as hepatitis B.