NCT01103687

Brief Summary

The purpose of this study is to evaluate the safety and immune response of an adenovirus-based 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
24

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Timeline
Completed

Started Jul 2010

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

April 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 8, 2017

Status Verified

September 1, 2017

Enrollment Period

2.2 years

First QC Date

April 13, 2010

Last Update Submit

September 5, 2017

Conditions

HIV Infections

Keywords

HIV Preventive Vaccine

Outcome Measures

Primary Outcomes (2)

  • Local and systemic reactions to vaccine

    Measured through the 18-month follow-up visit

  • Adverse and serious adverse experiences

    Measured through the 18-month follow-up visit

Secondary Outcomes (5)

  • Innate immune responses, including cytokine levels and natural killer (NK) cell populations

    Measured through the 18-month follow-up visit

  • Humoral immune responses, including neutralizing antibodies against HIV and Ad26 and binding antibodies

    Measured through the 18-month follow-up visit

  • Cell mediated immunity, including T-cell gamma interferon responses by enzyme-linked immunosorbent spot (ELISPOT) and T-cell responses by flow cytometry

    Measured through the 18-month follow-up visit

  • Mucosal immune responses, including histopathology and T-cell responses by flow cytometry

    Measured through the 18-month follow-up visit

  • Genotyping

    Measured through the 18-month follow-up visit

Study Arms (2)

Ad26.ENVA.01 (rAd26)

EXPERIMENTAL

Participants will receive the Ad26.ENVA.01 (rAd26) vaccine at baseline.

Biological: Ad26.ENVA.01 (rAd26)

Placebo Vaccine

PLACEBO COMPARATOR

Participants will receive the placebo vaccine at baseline.

Biological: Placebo Vaccine

Interventions

Ad26.ENVA.01 (rAd26)BIOLOGICAL

5 x 10\^10 virus particles (VP) vaccine delivered intramuscularly (IM)

Ad26.ENVA.01 (rAd26)
Placebo VaccineBIOLOGICAL

Placebo vaccine delivered IM

Also known as: FFB, final formula buffer
Placebo Vaccine

Eligibility Criteria

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

You may qualify if:

  • Willing to be followed for the planned duration of the study
  • Able and willing to provide informed consent
  • Assessment of understanding, including the completion of a questionnaire prior to vaccination; verbally demonstrated understanding of all questionnaire items answered incorrectly
  • Willing to receive HIV test results
  • In good general health as shown by medical history, physical exam, and screening laboratory tests
  • Hemoglobin levels greater than or equal to 11.0 g/dL for women and greater than or equal to 12.5 g/dL for men
  • White blood cell (WBC) count between 3,300 and 12,000 cells/mm3
  • Total lymphocyte count greater than or equal to 800 cells/mm3
  • Remaining differential either within institutional normal range or accompanied by site physician approval
  • Platelet levels between 125,000 and 550,000/mm3
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin less than 1.25 times the institutional upper limit of normal; and creatinine less than or equal to the institutional upper limit of normal
  • Negative HIV-1 and 2 blood test
  • Negative hepatitis B surface antigen (HBsAg)
  • Negative anti-hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
  • Normal urine test; more information about this criterion can be found in the protocol
  • +2 more criteria

You may not qualify if:

  • Received HIV vaccine(s) in a prior HIV vaccine trial. Participants who received a control/placebo in an HIV vaccine trial are not excluded but documentation of the identity of the study control/placebo must be obtained.
  • Immunosuppressive medications received within 168 days before vaccination (e.g., oral/parenteral corticosteroids, and/or cytotoxic medications). People taking corticosteroid nasal spray for allergic rhinitis and topical corticosteroids for mild, uncomplicated dermatitis are not excluded.
  • Blood products received within 120 days before vaccination
  • Immunoglobulin received within 60 days before vaccination
  • Live attenuated vaccines received within 30 days before vaccination (e.g., measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever; Flumist® influenza)
  • Investigational research agents received within 30 days before vaccination
  • Any vaccines that are not live attenuated vaccines and were received within 14 days prior to vaccination (e.g., influenza, tetanus, pneumococcal, Hepatitis A or B)
  • Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. More information on this criterion can be found in the protocol.
  • Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participant's ability to give informed consent
  • Serious adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. People who had a nonanaphylactic adverse reaction to the pertussis vaccine as a child are not excluded.
  • Known autoimmune disease
  • Known immunodeficiency
  • Active syphilis infection. People who had syphilis that was fully treated more than 6 months before study entry are not excluded.
  • Asthma other than mild, well-controlled asthma. More information on this criterion can be found in the protocol.
  • Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. People with a history of isolated gestational diabetes are not excluded.
  • +17 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, 02115-6110, United States

Location

Related Publications (3)

  • Mast TC, Kierstead L, Gupta SB, Nikas AA, Kallas EG, Novitsky V, Mbewe B, Pitisuttithum P, Schechter M, Vardas E, Wolfe ND, Aste-Amezaga M, Casimiro DR, Coplan P, Straus WL, Shiver JW. International epidemiology of human pre-existing adenovirus (Ad) type-5, type-6, type-26 and type-36 neutralizing antibodies: correlates of high Ad5 titers and implications for potential HIV vaccine trials. Vaccine. 2010 Jan 22;28(4):950-7. doi: 10.1016/j.vaccine.2009.10.145. Epub 2009 Nov 17.

    PMID: 19925902BACKGROUND

  • 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

  • Baden LR, Liu J, Li H, Johnson JA, Walsh SR, Kleinjan JA, Engelson BA, Peter L, Abbink P, Milner DA Jr, Golden KL, Viani KL, Stachler MD, Chen BJ, Pau MG, Weijtens M, Carey BR, Miller CA, Swann EM, Wolff M, Loblein H, Seaman MS, Dolin R, Barouch DH. Induction of HIV-1-specific mucosal immune responses following intramuscular recombinant adenovirus serotype 26 HIV-1 vaccination of humans. J Infect Dis. 2015 Feb 15;211(4):518-28. doi: 10.1093/infdis/jiu485. Epub 2014 Aug 26.

    PMID: 25165165DERIVED

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

    Brigham and Women's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2010

First Posted

April 15, 2010

Study Start

July 1, 2010

Primary Completion

September 1, 2012

Study Completion

May 1, 2016

Last Updated

September 8, 2017

Record last verified: 2017-09

Locations

US(1)