HIV vaccine race: which shot schedule wins?
NCT ID NCT00490074
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two different schedules of an experimental HIV vaccine in 147 healthy adults to see which one triggers a stronger immune response. Volunteers received either three DNA shots followed by one booster, or two DNA shots followed by two boosters. The goal was to find a safe and effective way to train the body to fight HIV. Participants were monitored for 72 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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147 people
The number who actually took part.
- Start date
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Jul 2007
- Finished
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Oct 2009
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * age between 18 and 55 years on the day of screening * available for follow-up for the duration of the study (78 weeks from screening) * able to give written informed consent * at low risk of HIV and willing to remain so for the duration of the study low risk of HIV infection defined as: * no history of injecting drug use in the previous ten years * no gonorrhoea or syphilis in the last six months * no high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months * no unprotected anal intercourse in the last six months, outside a relationship with a regular partner known to be HIV negative * no unprotected vaginal intercourse in the last six months outside a relationship with a regular known/presumed HIV negative partner * willing to undergo a HIV test * willing to undergo a genital infection screen * if heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable contraceptive; IUCD; consistent record with condoms if using these; physiological or anatomical sterility in self or partner) from 14 days prior to the first vaccination until 4 months after the last, and willing to undergo urine pregnancy tests prior to each vaccination * if heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination * for French volunteers only : * subjects registered in French Health ministry computerised file and authorised to participate in a clinical trial * subjects covered by Health Insurance * subjects included in the ANRS vaccine research network of volunteers Exclusion Criteria: * pregnant or lactating * clinically relevant abnormality on history or examination including history of grand-mal epilepsy; severe eczema; allergy to eggs or gentamicin; severe allergic diseases; liver disease with inadequate hepatic function; haematological, metabolic or gastrointestinal disorders; uncontrolled infection; autoimmune disease, immunodeficiency or use of immunosuppressives in preceding 3 months * receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment * receipt of blood products or immunoglobin within 4 months of screening * participation in another trial of a medicinal product, completed less than 30 days prior to enrolment * history of severe local or general reaction to vaccination defined as * local: extensive, indurated redness and swelling involving most of the anterolateral thigh or the major circumference of the arm, not resolving within 72 hours * general: fever \>= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours * HIV 1/2 positive or indeterminate on screening * positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment * positive for DNA/ANA antibodies at titre considered clinically relevant by immunology laboratory * grade 1 or above routine laboratory parameters (see section 4.1.4 \& appendix 4 for definitions) Note of clarification 18th april 2008: hyperbilirubinemia has to be considered as an exclusion criterion only when confirmed to be conjugated bilirubinemia * unlikely to comply with protocol
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, 1011, Switzerland
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Hôpital Henri Mondor
Créteil, 94010, France
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Other studies related to the condition(s) this trial covers.
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