Book 5: Women

Women, including those of child-bearing potential, who are pregnant or breast-feeding, should be recipients of future HIV preventive vaccines. Therefore, women should be included in clinical trials to verify safety, immunogenicity, and efficacy from their standpoint. However, the involvement of such women must be based on a sound risk-benefit analysis, and their informed consent.

17.1 In many communities throughout the world women are at high risk of HIV infection. Therefore, the safety, immunogenicity, and efficacy of candidate vaccines should be established for women, and for their fetus and breast-fed child, where applicable. Women, including women of child-bearing potential, pregnant women, and breast-feeding women, are thus eligible for enrolment in HIV preventive vaccine trials. They are also eligible on equity grounds.

17.2 The enrolment of pregnant and breast-feeding women should take place only:

1. After appropriate studies on less vulnerable participants have been conducted;
2. If a favourable balance of risks and benefits is established (see Book 1,7.1.3 and 9.12.4.8);
3. With their informed consent (see Points 12 and 13). Such participants must be informed of and understand any potential for terato-genesis or other risks to the fetus, and/or the breast-fed infant;
4. If risk-minimisation measures are undertaken, e. g. if there are risks related to breast-feeding, nutritional substitutes and other supportive services should be made available and participants should be informed of such (see Points 12 and 13); and
5. In certain circumstances, recognition should be given to the interests of the father of the fetus to participate in decision-making (see Book 1, 5.3.1.1.3).

17.3 This guidance point must be read in conjunction with Book 1, 5.3.1.1.3; and 9.12.4.8.