NCT01435135

Brief Summary

The purpose of this study is to assess safety and tolerability of late boost regimens of AIDSVAX B/E alone, ALVAC-HIV alone, or ALVAC-HIV/AIDSVAX B/E combination in HIV-uninfected participants from RV 144.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
162

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Timeline
Completed

Started Apr 2012

Longer than P75 for phase_2 hiv-infections

Geographic Reach
1 country

2 active sites

Status
unknown

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

September 8, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

9.3 years

First QC Date

September 8, 2011

Last Update Submit

November 2, 2020

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (7)

  • Primary Immunogenicity Endpoint

    Characterization of vaccine-induced immune responses by IFN-gamma ELISPOT, intracellular cytokine staining (ICS), and 3H-thymidine incorporation assay.

    Week 0

  • Safety Endpoints

    Post-vaccination reactions including erythema, induration, pain/tenderness, swelling, limitation of arm movement, fever, tiredness, chills, myalgia, arthralgia, headache, nausea, dizziness, and rash will be assessed and recorded on diary cards.

    During the 3 days post-vaccination

  • Primary Immunogenicity Endpoint

    Characterization of vaccine-induced immune responses by IFN-gamma ELISPOT, intracellular cytokine staining (ICS), and 3H-thymidine incorporation assay.

    Week 2

  • Primary Immunogenicity Endpoint

    Characterization of vaccine-induced immune responses by IFN-gamma ELISPOT, intracellular cytokine staining (ICS), and 3H-thymidine incorporation assay.

    Week 24

  • Primary Immunogenicity Endpoint

    Characterization of vaccine-induced immune responses by IFN-gamma ELISPOT, intracellular cytokine staining (ICS), and 3H-thymidine incorporation assay.

    Week 26

  • Primary Immunogenicity Endpoint

    Characterization of vaccine-induced immune responses by IFN-gamma ELISPOT, intracellular cytokine staining (ICS), and 3H-thymidine incorporation assay.

    Week 48

  • Primary Immunogenicity Endpoint

    Characterization of vaccine-induced immune responses by IFN-gamma ELISPOT, intracellular cytokine staining (ICS), and 3H-thymidine incorporation assay.

    Week 72

Secondary Outcomes (1)

  • Secondary Immunogenicity Endpoints

    Baseline, Weeks 2, 24, 26, 48 and 72

Study Arms (3)

Group I

EXPERIMENTAL

ALVAC-HIV + AIDSVAX B/E or ALVAC-HIV placebo + AIDSVAX B/E placebo at Weeks 0 and 24

Biological: ALVAC-HIVBiological: AIDSVAX B/EBiological: ALVAC-HIV PlaceboBiological: AIDSVAX B/E Placebo

Group II

EXPERIMENTAL

AIDSVAX B/E or AIDSVAX B/E placebo at Weeks 0 and 24

Biological: AIDSVAX B/EBiological: AIDSVAX B/E Placebo

Group III

EXPERIMENTAL

ALVAC-HIV or ALVAC-HIV placebo at Weeks 0 and 24

Biological: ALVAC-HIVBiological: ALVAC-HIV Placebo

Interventions

ALVAC-HIVBIOLOGICAL

1 mL per injection containing 10\^6 CCID50/dose administered

Also known as: (vCP1521)
Group IGroup III
AIDSVAX B/EBIOLOGICAL

1 mL per injection (300 ug dose/antigen for a total of 600ug/dose administered)

Group IGroup II
ALVAC-HIV PlaceboBIOLOGICAL

1 ml per injection

Group IGroup III
AIDSVAX B/E PlaceboBIOLOGICAL

1 ml per injection

Group IGroup II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have participated in RV144, received the active product, and completed all 4 vaccination visits per protocol.
  • Must be able to understand and complete the informed consent process.
  • Must successfully complete a Test of Understanding prior to enrollment
  • The volunteer must answer 80% or 8 out of 10 of the questions correctly including two compulsory questions answered correctly.
  • If the volunteer is unable to do so, he or she will be given two more opportunities to repeat the TOU.
  • If after three attempts to pass the TOU the volunteer is still unable to do so, the volunteer will become ineligible for study participation.
  • Must be in good general health without clinically significant medical history.
  • HIV-uninfected per predefined algorithm within 45 days of enrollment.
  • Laboratory screening analysis
  • Hemoglobin: Women ≥12.0 g/dL. Men ≥12.5 g/dL
  • White cell count: 4,000 to 11,000 cells/mm3
  • Platelets: 150,000 to 450,000/mm3
  • Normal liver function: ALT/AST ≤1.25 institutional upper limit of reference range
  • Creatinine: ≤1.25 institutional upper limit of reference range
  • Urinalysis (dipstick) for blood and protein no greater than 1+, glucose negative
  • +3 more criteria

You may not qualify if:

  • \. Women breast-feeding or pregnant (positive pregnancy test) or planning to become pregnant during the window between study enrollment and 3 months after the last vaccination visit.
  • History of anaphylaxis or other serious adverse reaction to vaccines including to RV 144 vaccines, or allergies or reactions likely to be exacerbated by any component of the vaccine or placebo, including eggs, egg products, streptomycin, or neomycin.
  • Subject has received any of the following substances:
  • Chronic use of therapies which may modify immune response, such as IV immune globulin and systemic corticosteroids (in doses of \> 20 mg/day prednisone equivalent for periods exceeding 10 days).
  • The following exceptions are permitted and will not exclude study participation: use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single injection) of corticosteroid for a nonchronic condition (based on investigator clinical judgment) at least 2 weeks prior to enrollment in this study.
  • Blood products within 120 days prior to HIV screening.
  • Immunoglobulins within 14 days prior to HIV screening.
  • Any vaccine within 14 days prior to initial study vaccine administration in the present study.
  • Receipt of investigational HIV vaccine product other than the RV 144 regimen.
  • Investigational research agents within 30 days prior to initial study vaccine administration in the present study.
  • Use of anti-tuberculosis prophylaxis or therapy during the past 90 days.
  • Any medical, psychiatric, social condition, occupational reason, or other responsibility that, in the judgment of the investigator, is a contraindication to protocol compliance or impairs a subject's ability to give informed consent.
  • Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within 5 years prior to enrollment, a history of suicide plan or attempt.
  • Study site employees who are involved in the protocol and/or may have direct access to study related area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bang Lamung District Hospital

Chon Buri, Thailand

Location

Phan Thong District Hospital

Chon Buri, Thailand

Location

Related Publications (4)

  • Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, Premsri N, Namwat C, de Souza M, Adams E, Benenson M, Gurunathan S, Tartaglia J, McNeil JG, Francis DP, Stablein D, Birx DL, Chunsuttiwat S, Khamboonruang C, Thongcharoen P, Robb ML, Michael NL, Kunasol P, Kim JH; MOPH-TAVEG Investigators. Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N Engl J Med. 2009 Dec 3;361(23):2209-20. doi: 10.1056/NEJMoa0908492. Epub 2009 Oct 20.

    PMID: 19843557BACKGROUND

  • Williams LD, Shen X, Sawant SS, Akapirat S, Dahora LC, Tay MZ, Stanfield-Oakley S, Wills S, Goodman D, Tenney D, Spreng RL, Zhang L, Yates NL, Montefiori DC, Eller MA, Easterhoff D, Hope TJ, Rerks-Ngarm S, Pittisuttithum P, Nitayaphan S, Excler JL, Kim JH, Michael NL, Robb ML, O'Connell RJ, Karasavvas N, Vasan S, Ferrari G, Tomaras GD; RV305 study team. Viral vector delivered immunogen focuses HIV-1 antibody specificity and increases durability of the circulating antibody recall response. PLoS Pathog. 2023 May 31;19(5):e1011359. doi: 10.1371/journal.ppat.1011359. eCollection 2023 May.

    PMID: 37256916DERIVED

  • Rerks-Ngarm S, Pitisuttithum P, Excler JL, Nitayaphan S, Kaewkungwal J, Premsri N, Kunasol P, Karasavvas N, Schuetz A, Ngauy V, Sinangil F, Dawson P, deCamp AC, Phogat S, Garunathan S, Tartaglia J, DiazGranados C, Ratto-Kim S, Pegu P, Eller M, Karnasuta C, Montefiori DC, Sawant S, Vandergrift N, Wills S, Tomaras GD, Robb ML, Michael NL, Kim JH, Vasan S, O'Connell RJ; RV305 Study Team. Randomized, Double-Blind Evaluation of Late Boost Strategies for HIV-Uninfected Vaccine Recipients in the RV144 HIV Vaccine Efficacy Trial. J Infect Dis. 2017 Apr 15;215(8):1255-1263. doi: 10.1093/infdis/jix099.

    PMID: 28329190DERIVED

  • Easterhoff D, Moody MA, Fera D, Cheng H, Ackerman M, Wiehe K, Saunders KO, Pollara J, Vandergrift N, Parks R, Kim J, Michael NL, O'Connell RJ, Excler JL, Robb ML, Vasan S, Rerks-Ngarm S, Kaewkungwal J, Pitisuttithum P, Nitayaphan S, Sinangil F, Tartaglia J, Phogat S, Kepler TB, Alam SM, Liao HX, Ferrari G, Seaman MS, Montefiori DC, Tomaras GD, Harrison SC, Haynes BF. Boosting of HIV envelope CD4 binding site antibodies with long variable heavy third complementarity determining region in the randomized double blind RV305 HIV-1 vaccine trial. PLoS Pathog. 2017 Feb 24;13(2):e1006182. doi: 10.1371/journal.ppat.1006182. eCollection 2017 Feb.

    PMID: 28235027DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

AIDSVAXAIDSVAX B-E

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

  • Supachai Rerks-Ngarm, MD

    Department of Disease Control, Ministry of Public Health, Nonthaburi, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2011

First Posted

September 15, 2011

Study Start

April 1, 2012

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

November 3, 2020

Record last verified: 2020-11

Locations

TH(2)