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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000746 |
Purpose
Primary: To determine in healthy volunteers whether priming with a vaccinia HIV-1 gp160 envelope gene recombinant vaccine (HIVAC-1e) followed by boosting with one of two subunit recombinant HIV-1 envelope vaccines (Env 2-3 and gp120) provides enhanced immunogenicity compared to vaccination with the gp120 subunit vaccine alone. (Per 10/01/92 amendment, boosts with VaxSyn (gp160) were eliminated.) To evaluate the immunogenicity of one versus two priming doses of HIVAC-1e prior to a boost with gp120. To compare the relative immunogenicity of the three subunit vaccines when administered as boosters.
Secondary: To examine the safety of administering the individual subunit vaccines in combination with HIVAC-1e and the safety of administering the gp120 subunit vaccine alone.
In a previous study of candidate HIV vaccines, the evidence suggested that administration of a booster vaccination with a different vaccine preparation may produce a better immune response than administration of HIVAC-1e vaccine alone.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Biological: rgp120/HIV-1 SF-2 Biological: Env 2-3 Biological: HIVAC-1e Biological: gp160 Vaccine (MicroGeneSys) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention, Safety Study |
| Official Title: | A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines |
| Estimated Enrollment: | 56 |
In a previous study of candidate HIV vaccines, the evidence suggested that administration of a booster vaccination with a different vaccine preparation may produce a better immune response than administration of HIVAC-1e vaccine alone.
Seventy healthy volunteers are randomized to one of four groups. Groups A and D receive one initial immunization with HIVAC-1e followed by two boosts with subunit gp120 and Env 2-3, respectively, at months 8 and 12. Group B receives two immunizations with HIVAC-1e at months 0 and 8 followed by a single boost with subunit gp120 at month 12. Group C receives three doses of subunit gp120 only at months 0, 8 and 12. (Per 10/01/92 amendment, boosts with VaxSyn (gp160) have been eliminated.) Subjects are followed for 18 months.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Subjects must have:
Prior Medication: Required:
Exclusion Criteria
Co-existing Condition:
Subjects with the following symptoms or conditions are excluded:
Subjects with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Contacts and Locations| United States, Maryland | |
| Johns Hopkins Univ / School of Hygiene & Public Health | |
| Baltimore, Maryland, United States, 212051901 | |
| United States, Missouri | |
| St Louis Univ School of Medicine | |
| St. Louis, Missouri, United States, 63104 | |
| United States, New York | |
| Univ of Rochester Med Ctr | |
| Rochester, New York, United States, 14642 | |
| United States, Tennessee | |
| Vanderbilt Univ Hosp | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Washington | |
| Univ of Washington / Pacific Med Ctr | |
| Seattle, Washington, United States, 98144 | |
| Study Chair: | Corey L |
More Information
| Study ID Numbers: | AVEG 008, AVEG Protocol 008 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000746 History of Changes |
| Health Authority: | United States: Federal Government |
|
Vaccines, Synthetic Vaccinia Virus Viral Vaccines HIV-1 HIV Envelope Protein gp160 |
HIV Envelope Protein gp120 AIDS Vaccines HIV Seronegativity HIV Preventive Vaccine |
|
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Vaccinia Acquired Immunodeficiency Syndrome Infection Immunologic Deficiency Syndromes |
Virus Diseases Poxviridae Infections HIV Infections Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections Retroviridae Infections |