NCT01937455

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of rAAV1-PG9DP when administered intramuscularly at different dose levels in healthy male adults.

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
21

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Timeline
Completed

Started Sep 2014

Typical duration for phase_1 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 4, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

January 11, 2018

Status Verified

January 1, 2018

Enrollment Period

3.4 years

First QC Date

September 4, 2013

Last Update Submit

January 9, 2018

Conditions

HIV Infections

Keywords

HIVAIDSHIV vaccineHIV preventionAAVPG9

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

    1. Proportion of volunteers with moderate or greater reactogenicity (i.e., solicited adverse events) during a 7 day follow-up period after the injection 2. Proportion of volunteers with moderate or greater adverse events (i.e. unsolicited adverse events) including safety laboratory (biochemical, haematological) parameters, from the day of the injection up to 180 days post injection 3. Proportion of volunteers with serious adverse events (SAEs) related to the IMP throughout the study period 4. The proportion of volunteers in each group with Adverse Event of Special Interest, defined as adverse events potentially caused by antigen-antibody complexes or immune responses directed to cells producing the transgene

    12 months

Secondary Outcomes (1)

  • Pharmacokinetics and Immunogenicity

    12 months

Study Arms (4)

Group A

EXPERIMENTAL

rAAV1-PG9DP or placebo (v:p = 3:1)

Biological: rAAV1-PG9DP

Group B

EXPERIMENTAL

rAAV1-PG9DP or placebo (v:p = 3:1)

Biological: rAAV1-PG9DP

Group C/C1

EXPERIMENTAL

rAAV1-PG9DP or placebo (v:p = 3:1 in Group C, and v:p = 9:3 in Group C1)

Biological: rAAV1-PG9DP

Group D/D1

EXPERIMENTAL

rAAV1-PG9DP or placebo (v:p = 3:1 in Group D, v:p = 4:1 in Group D1)

Biological: rAAV1-PG9DP

Interventions

rAAV1-PG9DPBIOLOGICAL

4x10\^12 vg administered intramuscularly

Group A

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male.
  • to 45 years of age.
  • Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
  • In the opinion of the Principal Investigator or designee and based on Assessment of Informed Consent Understanding results, has understood the information provided and has provided informed consent.
  • Willing to undergo HIV testing, risk reduction counseling and receive HIV test results.
  • All sexually active males must be willing to use male condoms with all sexual partners (female or male) from the day of first injection until 3 months after the injection.
  • Willing to forgo donations of blood or any other tissues during the study and, for those who test HIV-positive due to vaccine-induced antibodies, until the anti-HIV antibody titers become undetectable.

You may not qualify if:

  • Confirmed HIV-1 or HIV-2 infection.
  • Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the investigator within the previous 6 months.
  • Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the investigator makes the volunteer unsuitable for participation in the study.
  • Any of the following specific risk behaviour for HIV infection within 6 months prior to injection:
  • Unprotected sexual intercourse with a known HIV infected person or a partner known to be at high risk for HIV infection or a casual partner (i.e., no continuing established relationship)
  • Unprotected anal intercourse with another man (either insertive or receptive)
  • Three or more sexual partners
  • Engaged in sex work
  • Frequent excessive daily alcohol use or frequent binge drinking or chronic marijuana abuse or any other use of illicit drugs
  • History of newly-acquired syphilis, gonorrhea, non-gonococcal urethritis, HSV-2, chlamydia, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B
  • Bleeding disorder that was diagnosed by a physician (e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions).
  • Clinically significant laboratory abnormalities.
  • Anti-AAV1 antibody level above the cut-off.
  • Receipt of live attenuated vaccine within the previous 60 days or planned receipt within 60 days after injection with IP; or receipt of other vaccine within the previous 14 days or planned receipt within 14 days after injection with IP (exception is live attenuated influenza vaccine within 14 days).
  • Receipt of blood transfusion or blood-derived products within the previous 3 months.
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Surrey Clinical Research Centre

Guildford, GU2 7XP, United Kingdom

Location

Southampton Centre for Biomedical Research

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (2)

  • Libera M, Caputo V, Laterza G, Moudoud L, Soggiu A, Bonizzi L, Diotti RA. The Question of HIV Vaccine: Why Is a Solution Not Yet Available? J Immunol Res. 2024 Apr 8;2024:2147912. doi: 10.1155/2024/2147912. eCollection 2024.

    PMID: 38628675DERIVED

  • Priddy FH, Lewis DJM, Gelderblom HC, Hassanin H, Streatfield C, LaBranche C, Hare J, Cox JH, Dally L, Bendel D, Montefiori D, Sayeed E, Ackland J, Gilmour J, Schnepp BC, Wright JF, Johnson P. Adeno-associated virus vectored immunoprophylaxis to prevent HIV in healthy adults: a phase 1 randomised controlled trial. Lancet HIV. 2019 Apr;6(4):e230-e239. doi: 10.1016/S2352-3018(19)30003-7. Epub 2019 Mar 15.

    PMID: 30885692DERIVED

Related Links

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • David JM Lewis

    Clinical Research Centre, Institute of Biosciences and Medicine, FHMS, University of Surrey

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 4, 2013

First Posted

September 9, 2013

Study Start

September 1, 2014

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

January 11, 2018

Record last verified: 2018-01

Locations

GB(2)