NCT00124007

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Nov 2005

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

First QC Date

July 22, 2005

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

HIV SeronegativityHIV Preventive Vaccine

Outcome Measures

Primary Outcomes (4)

  • Local reactogenicity signs and symptoms

  • systemic reactogenicity signs and symptoms

  • laboratory measures of safety

  • adverse and serious adverse experiences

Secondary Outcomes (5)

  • 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.

Interventions

VRC-HIVADV014-00-VPBIOLOGICAL
VRC-HIVDNA016-00-VPBIOLOGICAL

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

KEMRI, Ctr. for Geographic Medicine Research Coast at Kilifi

Kilifi, Kenya

Location

KAVI, KNH at Kangemi

Nairobi, Kenya

Location

Projet San Francisco

Kigali, Rwanda

Location

Related Publications (5)

  • Esparza J, Osmanov S. HIV vaccines: a global perspective. Curr Mol Med. 2003 May;3(3):183-93. doi: 10.2174/1566524033479825.

    PMID: 12699356BACKGROUND

  • 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.

    PMID: 12089434BACKGROUND

  • 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.

    PMID: 14738219BACKGROUND

  • 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.

    PMID: 21283743DERIVED

  • 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.

    PMID: 20877623DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Job Bwayo, MD, PhD

    Kenya AIDS Vaccine Initiative, University of Nairobi

    PRINCIPAL INVESTIGATOR

  • Etienne Karita, MD

    Project San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2005

First Posted

July 26, 2005

Study Start

November 1, 2005

Study Completion

April 1, 2007

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

RW(1)KE(2)