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Safety of and Immune Response to an Adenoviral HIV Vaccine (VRC-HIVADV014-00-VP) With or Without a Plasmid HIV Vaccine (VRC-HIVDNA016-00-VP) in HIV Uninfected Adults

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
VRC-HIVADV014-00-VP
VRC-HIVDNA016-00-VP
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HIV Infections focused on measuring HIV Seronegativity, HIV Preventive Vaccine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Willing to follow all the requirements of the study and available for follow-up for the duration of the study Have understanding of the study and provide written informed consent Willing to undergo HIV testing and counseling and willing to receive HIV test results Willing to use acceptable forms of contraception Exclusion Criteria: HIV infected Hepatitis B virus infected Hepatitis C virus infected Active or untreated syphilis Participated in high-risk behavior for HIV infection within 6 months prior to study entry. More information on this criterion can be found in the protocol. Any clinically significant abnormality in history or upon examination (e.g., immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the investigator) within 6 months prior to study entry Any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would make the volunteer unsuitable for the study Live attenuated vaccines within 30 days prior to study entry OR plan to receive a live attenuated vaccine within 60 days after vaccination in this study Subunit or killed vaccines within 14 days prior to study entry OR plan to receive a subunit or killed vaccine within 14 days after vaccination in this study Blood transfusion or blood products within 120 days prior to study entry Immunoglobulin within 60 days prior to study entry Participation in another investigational product clinical trial in the 3 months prior to study entry OR expected to participate in another investigational trial during this study Any other investigational HIV vaccine at any time History of severe local or systemic reactogenicity to vaccines or history of severe allergic reactions Major psychiatric illness, including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, or suicide attempt or suicidal thoughts within the 3 years prior to study entry Uncontrolled hypertension Pregnant, breastfeeding, or plan to become pregnant

Sites / Locations

  • KEMRI, Ctr. for Geographic Medicine Research Coast at Kilifi
  • KAVI, KNH at Kangemi
  • Projet San Francisco

Outcomes

Primary Outcome Measures

Local reactogenicity signs and symptoms
systemic reactogenicity signs and symptoms
laboratory measures of safety
adverse and serious adverse experiences

Secondary Outcome Measures

Proportion of volunteers who have HIV-1 specific T-cell responses quantified by intracellular cytokine staining (ICS; both CD4+ and CD8+) and ELISPOT and magnitude of the responses
proportion of volunteers with HIV-1 specific antibodies and magnitude of the response
proportion of volunteers with increase in antibodies to rAd5
impact of pre-existing immunity to rAd5 on immunogenicity
proportion of volunteers who test "false positive" on standard HIV testing algorithm.

Full Information

First Posted
July 22, 2005
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00124007
Brief Title
Safety of and Immune Response to an Adenoviral HIV Vaccine (VRC-HIVADV014-00-VP) With or Without a Plasmid HIV Vaccine (VRC-HIVDNA016-00-VP) in HIV Uninfected Adults
Official Title
A Phase I, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine Followed by Recombinant, Multiclade HIV-1 Adenoviral Vector Vaccine or the Multiclade HIV-1 Adenoviral Vector Vaccine Alone in Healthy Adult Volunteers Not Infected With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine the safety of and immune response to an investigational HIV vaccine, VRC-HIVADV014-00-VP, with or without a second investigational HIV vaccine, VRC-HIVDNA016-00-VP, in HIV uninfected adults.
Detailed Description
The worldwide HIV/AIDS epidemic may only be controlled through development of a safe and effective vaccine that will prevent HIV infection. This study will evaluate the safety and immunogenicity of an experimental adenovirus-vectored multiclade HIV vaccine, VRC-HIVADV014-00-VP, followed with either a similarly structured DNA plasmid HIV vaccine, VRC-HIVDNA016-00-VP, or a placebo. The DNA plasmids in both vaccines code for proteins from HIV subtypes A, B, and C, which together represent 90% of new HIV infections in the world. HIV uninfected volunteers will be recruited in Kenya and Rwanda. Volunteers will participate in this study for 1 year. Participants will be randomly assigned to one of four groups: Group A participants will receive a low dose of the adenovirus-vectored vaccine or placebo at study entry. Group B participants will receive a higher dose of the adenovirus-vectored vaccine or placebo at study entry. Group C participants will receive the DNA plasmid vaccine or placebo at study entry and Months 1 and 2. They will receive either a low dose of the adenovirus-vectored vaccine or placebo at Month 6. Group D participants will receive the DNA plasmid vaccine or placebo at study entry and Months 1 and 2. They will receive either a higher dose of the adenovirus-vectored vaccine or placebo at Month 6. All participants will undergo vital signs measurements before and after receiving each vaccination. Participants in Groups A and B will have 9 study visits over 12 months. A physical exam, adverse events reporting, and medical and medication history will occur at each visit. HIV testing and counseling and blood and urine collection will occur at selected visits. Participants in Groups C and D will have 17 study visits over 12 months. A physical exam, adverse events reporting, and medical and medication history will occur at each visit. HIV testing and counseling and blood and urine collection will occur at selected visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Seronegativity, HIV Preventive Vaccine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
VRC-HIVADV014-00-VP
Intervention Type
Biological
Intervention Name(s)
VRC-HIVDNA016-00-VP
Primary Outcome Measure Information:
Title
Local reactogenicity signs and symptoms
Title
systemic reactogenicity signs and symptoms
Title
laboratory measures of safety
Title
adverse and serious adverse experiences
Secondary Outcome Measure Information:
Title
Proportion of volunteers who have HIV-1 specific T-cell responses quantified by intracellular cytokine staining (ICS; both CD4+ and CD8+) and ELISPOT and magnitude of the responses
Title
proportion of volunteers with HIV-1 specific antibodies and magnitude of the response
Title
proportion of volunteers with increase in antibodies to rAd5
Title
impact of pre-existing immunity to rAd5 on immunogenicity
Title
proportion of volunteers who test "false positive" on standard HIV testing algorithm.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Willing to follow all the requirements of the study and available for follow-up for the duration of the study Have understanding of the study and provide written informed consent Willing to undergo HIV testing and counseling and willing to receive HIV test results Willing to use acceptable forms of contraception Exclusion Criteria: HIV infected Hepatitis B virus infected Hepatitis C virus infected Active or untreated syphilis Participated in high-risk behavior for HIV infection within 6 months prior to study entry. More information on this criterion can be found in the protocol. Any clinically significant abnormality in history or upon examination (e.g., immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the investigator) within 6 months prior to study entry Any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would make the volunteer unsuitable for the study Live attenuated vaccines within 30 days prior to study entry OR plan to receive a live attenuated vaccine within 60 days after vaccination in this study Subunit or killed vaccines within 14 days prior to study entry OR plan to receive a subunit or killed vaccine within 14 days after vaccination in this study Blood transfusion or blood products within 120 days prior to study entry Immunoglobulin within 60 days prior to study entry Participation in another investigational product clinical trial in the 3 months prior to study entry OR expected to participate in another investigational trial during this study Any other investigational HIV vaccine at any time History of severe local or systemic reactogenicity to vaccines or history of severe allergic reactions Major psychiatric illness, including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, or suicide attempt or suicidal thoughts within the 3 years prior to study entry Uncontrolled hypertension Pregnant, breastfeeding, or plan to become pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Job Bwayo, MD, PhD
Organizational Affiliation
Kenya AIDS Vaccine Initiative, University of Nairobi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Etienne Karita, MD
Organizational Affiliation
Project San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
KEMRI, Ctr. for Geographic Medicine Research Coast at Kilifi
City
Kilifi
Country
Kenya
Facility Name
KAVI, KNH at Kangemi
City
Nairobi
Country
Kenya
Facility Name
Projet San Francisco
City
Kigali
Country
Rwanda

12. IPD Sharing Statement

Citations:
PubMed Identifier
12699356
Citation
Esparza J, Osmanov S. HIV vaccines: a global perspective. Curr Mol Med. 2003 May;3(3):183-93. doi: 10.2174/1566524033479825.
Results Reference
background
PubMed Identifier
12089434
Citation
Gaschen B, Taylor J, Yusim K, Foley B, Gao F, Lang D, Novitsky V, Haynes B, Hahn BH, Bhattacharya T, Korber B. Diversity considerations in HIV-1 vaccine selection. Science. 2002 Jun 28;296(5577):2354-60. doi: 10.1126/science.1070441.
Results Reference
background
PubMed Identifier
14738219
Citation
Stratov I, DeRose R, Purcell DF, Kent SJ. Vaccines and vaccine strategies against HIV. Curr Drug Targets. 2004 Jan;5(1):71-88. doi: 10.2174/1389450043490686.
Results Reference
background
PubMed Identifier
21283743
Citation
Omosa-Manyonyi GS, Jaoko W, Anzala O, Ogutu H, Wakasiaka S, Malogo R, Nyange J, Njuguna P, Ndinya-Achola J, Bhatt K, Farah B, Oyaro M, Schmidt C, Priddy F, Fast P. Reasons for ineligibility in phase 1 and 2A HIV vaccine clinical trials at Kenya AIDS vaccine initiative (KAVI), Kenya. PLoS One. 2011 Jan 21;6(1):e14580. doi: 10.1371/journal.pone.0014580.
Results Reference
derived
PubMed Identifier
20877623
Citation
Jaoko W, Karita E, Kayitenkore K, Omosa-Manyonyi G, Allen S, Than S, Adams EM, Graham BS, Koup RA, Bailer RT, Smith C, Dally L, Farah B, Anzala O, Muvunyi CM, Bizimana J, Tarragona-Fiol T, Bergin PJ, Hayes P, Ho M, Loughran K, Komaroff W, Stevens G, Thomson H, Boaz MJ, Cox JH, Schmidt C, Gilmour J, Nabel GJ, Fast P, Bwayo J. Safety and immunogenicity study of Multiclade HIV-1 adenoviral vector vaccine alone or as boost following a multiclade HIV-1 DNA vaccine in Africa. PLoS One. 2010 Sep 21;5(9):e12873. doi: 10.1371/journal.pone.0012873.
Results Reference
derived

Learn more about this trial

Safety of and Immune Response to an Adenoviral HIV Vaccine (VRC-HIVADV014-00-VP) With or Without a Plasmid HIV Vaccine (VRC-HIVDNA016-00-VP) in HIV Uninfected Adults

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