vaccine. Women should be included in clinical trials to verify safety,
immunogecity and efficacy from their stand point. During such research,
women should research adequate information to make informed choices
about risks to themselves as well as their foetus and breastfeeding infant
where applicable.
•
Women, including pregnant and breastfeeding women should be eligible
for involvement in HIV vaccine trial both as a matter of equity and
because women are more at risk of HIV infection
18.
Guiding principal 18: Vaccine candidates. All HIV vaccine candidate
products to be tested must first be approved in safety and immunogenicity
trials in animal models. An evaluation trial with human subjects must comply
with the Zimbabwean IRB ;
19.
Guiding principal 19: Research of HIV vaccines may involve Phase I
(safety), Phase II (immunogenicity) or Phase III (effectiveness) trials. If the
study proposed is on safety or immunogenicity, the protocol should include a
plan for future effectiveness studies;
20.
Guiding principal 20: Before starting the study, the laboratory markers to be
used to distinguish between natural HIV infection and the immune response
to the vaccine product should be determined;
21.
Guiding principal 21: If the candidate HIV vaccine was developed abroad,
all the researchers, both from the country of origin and Zimbabwe, should
collaborate in all the stages of the study, from the development of protocols to
the diffusion of data;
27
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