NCT00695877

Brief Summary

Successful control of the HIV epidemic will require a safe and effective vaccine to be developed. A successful vaccine will need to stimulate a widespread immune response. The purpose of this study is to determine the safety of and immune response to an adenovirus serotype HIV vaccine in HIV uninfected adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

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

June 10, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

February 8, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2012

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2016

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

3.8 years

First QC Date

June 10, 2008

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

HIV SeronegativityHIV Preventive Vaccine

Outcome Measures

Primary Outcomes (1)

  • Local and systemic adverse reactions

    Throughout study

Secondary Outcomes (3)

  • Humoral Immune response

    Throughout study

  • Cell mediated immunity

    Throughout study

  • Genotyping

    Throughout study

Study Arms (4)

1

EXPERIMENTAL

3 injections of rAd5.ENVA.48 HIV-1 vaccine or placebo at 1 x 10\^9 virus particles (VP) given at Days 0, 28, and 168

Biological: Ad5.ENVA.48 HIV-1 vaccine

2

EXPERIMENTAL

3 injections of rAd5.ENVA.48 HIV-1 vaccine or placebo at 1 x 10\^10 virus particles (VP) given at Days 0, 28, and 168

Biological: Ad5.ENVA.48 HIV-1 vaccine

3

EXPERIMENTAL

3 injections of rAd5.ENVA.48 HIV-1 vaccine or placebo at 1 x 10\^11 virus particles (VP) given at Days 0, 28, and 168

Biological: Ad5.ENVA.48 HIV-1 vaccine

4

EXPERIMENTAL

1 injection of rAd5.ENVA.48 HIV-1 vaccine or placebo at a dose determined by the safety data from Arms 1, 2 and 3 given at Day 0.

Biological: Ad5.ENVA.48 HIV-1 vaccine

Interventions

Ad5.ENVA.48 HIV-1 vaccineBIOLOGICAL

Recombinant adenovirus serotype 5 HIV-1 vaccine

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Eligibility Criteria

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

You may qualify if:

  • Good general health
  • Normal hematological, hepatic and renal functions
  • Demonstrated understanding of study
  • Willing to receive HIV test results
  • HIV-1 and -2 uninfected
  • Hepatitis B surface antigen negative
  • Anti-hepatitis C virus (anti-HCV) negative antibody or negative HCV PCR if anti-HCV is positive
  • Adequate contraception. For more information on this criterion can be found in the protocol.

You may not qualify if:

  • HIV vaccines or placebos in prior HIV vaccine trial
  • Immunosuppressive medications within 168 days prior to first injection. Participants taking corticosteroid nasal spray or topical corticosteroids are not excluded.
  • Blood products within 120 days prior to first injection
  • Immunoglobulin within 60 days prior to first injection
  • Investigational agents within 30 days prior to first injections
  • Live attenuated vaccine within 30 days prior to first injection
  • Any vaccine that is not a live attenuated vaccine within 14 days prior to first injection
  • Any clinically significant medical condition that, in the opinion of the investigator, may interfere with the study
  • Any medical, psychiatric, occupational, or social condition or responsibility that, in the opinion of the investigator, would interfere with the study
  • Serious adverse reaction to vaccines. Participants who had a nonanaphylactic adverse reaction to pertussis vaccine as a child are not excluded.
  • Known autoimmune disease
  • Known immunodeficiency
  • Asthma other than mild, well-controlled asthma
  • Diabetes mellitus type 1 or 2
  • Thyroidectomy or thyroid disease in the12 months prior to study entry
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hosp. Novel Adenoviral Vector Prophylactic HIV Vaccine Non-Network CRS

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

  • Priddy FH, Brown D, Kublin J, Monahan K, Wright DP, Lalezari J, Santiago S, Marmor M, Lally M, Novak RM, Brown SJ, Kulkarni P, Dubey SA, Kierstead LS, Casimiro DR, Mogg R, DiNubile MJ, Shiver JW, Leavitt RY, Robertson MN, Mehrotra DV, Quirk E; Merck V520-016 Study Group. Safety and immunogenicity of a replication-incompetent adenovirus type 5 HIV-1 clade B gag/pol/nef vaccine in healthy adults. Clin Infect Dis. 2008 Jun 1;46(11):1769-81. doi: 10.1086/587993.

    PMID: 18433307BACKGROUND

  • Stevens W, Kamali A, Karita E, Anzala O, Sanders EJ, Jaoko W, Kaleebu P, Mulenga J, Dally L, Fast P, Gilmour J, Farah B, Birungi J, Hughes P, Manigart O, Stevens G, Yates S, Thomson H, von Lieven A, Krebs M, Price MA, Stoll-Johnson L, Ketter N. Baseline morbidity in 2,990 adult African volunteers recruited to characterize laboratory reference intervals for future HIV vaccine clinical trials. PLoS One. 2008 Apr 30;3(4):e2043. doi: 10.1371/journal.pone.0002043.

    PMID: 18446196BACKGROUND

  • Baden LR, Walsh SR, Seaman MS, Johnson JA, Tucker RP, Kleinjan JA, Gothing JA, Engelson BA, Carey BR, Oza A, Bajimaya S, Peter L, Bleckwehl C, Abbink P, Pau MG, Weijtens M, Kunchai M, Swann EM, Wolff M, Dolin R, Barouch DH. First-in-human evaluation of a hexon chimeric adenovirus vector expressing HIV-1 Env (IPCAVD 002). J Infect Dis. 2014 Oct 1;210(7):1052-61. doi: 10.1093/infdis/jiu217. Epub 2014 Apr 8.

    PMID: 24719474DERIVED

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

  • Lindsey Baden, MD

    Brigham and Women's Hospital

    STUDY CHAIR

  • Dan Barouch, MD

    Beth Israel Deaconess Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2008

First Posted

June 12, 2008

Study Start

February 8, 2009

Primary Completion

December 11, 2012

Study Completion

October 14, 2016

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

US(1)