Group 2: 2: Ethical, Ethical, Regulatory, Regulatory, & Community Issues

Transcription

1 Group 2: Ethical, Regulatory, & Group 2: Ethical, Regulatory, & Community Issues

2 Dr. Ruth Macklin (Chair), Albert Einstein i College of Medicine i Ms. Charla Andrews, USAMC-AFRIMS Mr. Kevin Fisher, AIDS Vaccine Advocacy Coalition Dr. Yupin Lawanprasert, Thai FDA Ms. Patricia Morgan, USAMC-AFRIMS Dr. Chawetsan Namwat, MOPH-Thailand Dr. Saladin Osmanov, WHO Dr. Punnee Pitisuttithum, Mahidol University Dr. Supachai Rerks-Ngarm, MOPH-Thailand Ms. Nusara Thaitawat, USAMC-AFRIMS Mr. Nimit Tienudom, AIDS-Access Foundation Note Taker: Ms. Liz Shoaf

3 The Ministry of Public Health, researchers, and sponsors have no obligation at this time to provide the RV144 vaccine regimen to the placebo group in the trial. The following reasons, taken together, are the justification for this recommendation. 1. The level of efficacy demonstrated in the trial is too low, and the confidence interval too, wide to warrant provision of this vaccine regimen to the placebo control group. 2. The roadmap established during the trial set the level of efficacy at 50%, which is higher than that demonstrated in the trial. This determination provided a reasonable expectation to the participants for what they would receive if they were in the placebo group. 3. There is insufficient data to support a conclusion about the durability of the RV144 vaccine regimen. 4. Providing the RV144 vaccine regimen to the placebo group may make them ineligible ibl for any possible benefits resulting from their participation i i in future trials. 5. A possibility of rare risks from the vaccine that did not show up in the RV144 trial, and the possibility of increased risk behavior, cannot be ruled out.

4 However, the volunteers who were in the placebo group for the RV144 trial should be given priority in the future for access to the RV144 vaccine regimen if it demonstrates sufficiently higher efficacy in future trials. Even if future trials show sufficient efficacy only in specific high risk groups, there may be a presumption that the RV144 vaccine regimen would be similarly il l efficacious i in a lower risk group, and therefore, appropriate for provision to the placebo group in the RV144 trial.

5 For reasons provided in recommendation #1, it is ethically acceptable to use a placebo control in a future trial of a vaccine of similar concept to the RV144 vaccine regimen. At present, the level of efficacy and unanswered scientific questions in the completed RV144 trial justify the use of placebos in other trials. Guidance point 15, Control Groups, in the UNAIDS/WHO Guidance Document states, a placebo control is ethically acceptable when there is no HIV prevention modality that t has been scientifically validated. d

6 For reasons provided in recommendation #1, the RV144 vaccine regimen does not meet the necessary requirements for inclusion in a prevention package. However, if after future trials this vaccine regimen is approved by the national regulatory authority, it must be provided in a prevention package of any future HIV preventive vaccine trial (Guidance point 13, Standards of Prevention, UNAIDS/WHO Guidance Document).

7 Protocols for future trials of the RV144 vaccine regimen and other HIV preventive vaccines should specify the level of efficacy required for provision of a successful product to the placebo group. This should also be included in the consent document.

8 As this is the first vaccine to demonstrate a level of efficacy, and given the contribution of Thailand in reaching this result, there are compelling scientific and ethical reasons to continue further vaccine research that may benefit the Thai people. The ethical reason is based on the principle of justice as reciprocity. 1. Given current knowledge, the Ministry of Public Health should encourage continued interpretation and expansion of the results of the RV144 trials in Thailand involving the RV144 vaccine regimen or other promising vaccine developments. 2. Researchers should seek answers to remaining scientific questions concerning the RV144 vaccine regimen in order to reach a conclusive outcome about efficacy in a timely manner.. 3. The Ministry of Public Health should encourage all efforts to pursue the development of new vaccine concepts that may be beneficial to the Thai population, in particular, the segment of the population at higher risk of HIV exposure.

9 Enhanced community participation should occur in all vaccine trials. The Ministry i of Public Health in its capacity of overseeing research in Thailand should ensure that researchers consult communities through a transparent and meaningful participatory process which involves them in an early and sustained manner in the design, development, implementation, and distribution of results of bio-medical HIV prevention trials. (Guidance point 2, Community Participation, UNAIDS/WHO Guidance Document).

10 Given the complexity of the RV144 trial results, the Ministry of Public Health in its capacity of overseeing research in Thailand, should seek to ensure that vaccine trial results and implications are communicated to the public in clear and understandable language. To this end, researchers should engage communities in consultation and dialogue throughout all stages of vaccine trials (UNAIDS/AVAC Good Participatory Practice Guidelines for biomedical prevention trials).