A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination With Soluble Recombinant Envelope Vaccine (VaxSyn)
HIVAC-1e
+ gp160 Vaccine (MicroGeneSys)
Infections transmises par le sang+14
+ Maladies génito-urinaires
+ Maladies Génitales
Étude de prévention
Résumé
Recent Phase I trials conducted at the AIDS Vaccine Units have shown that antibodies have persisted in most recipients for 6 months after boosting, and responses seem significantly higher and more persistent than responses achieved by just two doses of soluble protein vaccine alone or two doses of HIVAC-1e alone. This study tests in a previously recruited cohort of volunteers whether additional boosting with soluble recombinant gp160 results in increased immunogenicity of longer duration. Twelve volunteers who have previously received two doses of HIVAC-1e (or DryVax) and two doses of gp160 receive an additional boost of gp160 at 12-20 months after the last boost and an additional dose of HIVAC-1e at least 9 months after the final gp160 boost.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.13 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Prévention
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Homme
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 60 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria Patients must have: Normal history and physical exam. Negative ELISA for HIV. Negative HIV p24 antigen test. Normal urinalysis. Prior Medication: Required: Two prior doses of HIVAC-1e (or DryVax) and two prior doses of gp160 vaccine. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Risk factors for HIV infection including active intravenous drug use and more than 2 sexual partners. History of immunodeficiency or chronic illness. Hypersensitivity to insects. Medical or psychiatric condition that makes it unlikely the patient will comply with the protocol. Patients with the following prior conditions are excluded: History of immunodeficiency or chronic illness. Prior Medication: Excluded: Immunosuppressive medications. Prior Treatment: Excluded: Blood or blood product transfusion within the past 6 months. Risk Behavior: Excluded: Intravenous drug use. More than 2 sexual partners.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Children's Hospital & Medical Center / Seattle ACTU
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