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HIV InfectionsPhase 1NCT01937455

A Phase 1, Randomized, Blinded, Dose-escalation Study of rAAV1-PG9DP Recombinant AAV Vector Coding for PG9 Antibody in Healthy Male Adults.

A Phase 1 study testing rAAV1-PG9DP in people with HIV Infections, run by International AIDS Vaccine Initiative at 2 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
rAAV1-PG9DP
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
2 sitesUnited Kingdom
Study dates
Sep 2014to Feb 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male.
  • 18 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.

Who cannot join

  • 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)
Show all 30Show fewer
  • 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.
  • Participation in another clinical trial of an IMP currently, within the previous 3 months or expected participation during this study.
  • Prior receipt of another AAV vector, investigational HIV vaccine candidate, monoclonal antibody or polyclonal immunoglobulin (note: receipt of placebo in a previous HIV vaccine or monoclonal antibody trial will not exclude a volunteer from participation).
  • History of severe local or systemic reactogenicity to vaccines or infusions (e.g., anaphylaxis, respiratory difficulties, angioedema)
  • Psychiatric condition that compromises safety of the volunteer and precludes compliance with the protocol.
  • In the opinion of the Principal Investigator, it is not in the best interest of the volunteer to participate in the trial.
  • Seizure disorder: a participant who has had a seizure in the last 3 years.
  • ECG with clinically significant findings or features.
  • History of, or known active cardiovascular disease.
  • Have 3 or more of the following risk factors:
  • Hypertension diagnosed by a doctor
  • Hypercholesterolemia diagnosed by a doctor
  • Diabetes mellitus
  • Hyperglycemia diagnosed by a doctor
  • First degree relative (i.e., mother, father, brother, sister) who had a heart condition before the age of 50
  • Currently smoke cigarettes

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Surrey Clinical Research Centre

    Guildford, GU2 7XP

  • Southampton Centre for Biomedical Research

    Southampton, SO16 6YD

Other trials in United Kingdom

About this study

Official title: Safety and Immunogenicity Study of rAAV1-PG9DP Recombinant AAV Vector Coding for PG9 Antibody in Healthy Male Adults.

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.

Read the detailed description

This study is a phase 1, randomized, blinded, dose-escalation study to evaluate the safety and tolerability of rAAV1-PG9DP when administered intramuscularly at 4x10^12 vg, 4x10^13 vg, 8x10^13 vg and 1.2x10^14 vg in healthy male adults.

Volunteers will be screened up to 42 days before injection and will be followed for 12 months after the single administration. It is anticipated that it will take approximately 13 months to enroll the study.

Volunteers will be randomly assigned investigational product (IP) or placebo within each of the dose groups described in the study design table above depending on which group is enrolling. Study staff and volunteers will be blinded only with respect to the allocation of placebo or IP. Blinding will not apply to the assignment of dosage levels.

Volunteers will be offered enrollment into a follow-up study at the research center when they have finished participating in the trial

Conditions
HIV Infections
Being tested
rAAV1-PG9DP
Keywords
HIV, AIDS, HIV vaccine, HIV prevention, AAV, PG9
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rAAV1-PG9DPBiological

    4x10^12 vg administered intramuscularly

  • rAAV1-PG9DPBiological

    4x10^13 vg administered intramuscularly

  • rAAV1-PG9DPBiological

    8x10^13 vg administered intramuscularly

  • rAAV1-PG9DPBiological

    1.2x10^14 vg administered intramuscularly

Study groups in NCT01937455
Study groupRoleWhat they receive
Group AExperimentalrAAV1-PG9DP or placebo (v:p = 3:1)
Receives: Biological: rAAV1-PG9DP
Group BExperimentalrAAV1-PG9DP or placebo (v:p = 3:1)
Receives: Biological: rAAV1-PG9DP
Group C/C1ExperimentalrAAV1-PG9DP or placebo (v:p = 3:1 in Group C, and v:p = 9:3 in Group C1)
Receives: Biological: rAAV1-PG9DP
Group D/D1ExperimentalrAAV1-PG9DP or placebo (v:p = 3:1 in Group D, v:p = 4:1 in Group D1)
Receives: Biological: rAAV1-PG9DP

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (1)

  1. Pharmacokinetics and Immunogenicity

    To assess (qualitative and quantitative) immune responses elicited by the different dose levels.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2013 (estimated)
  2. Study startSep 2014
  3. Primary completionFeb 2018 (estimated)
  4. Study completionFeb 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01937455
Sponsor's protocol ID
IAVI A003/CHOP HVDDT 001
Other IDs
2013-002268-14, HHSN272201000021C
Status last verified
Jan 2018
First submitted
4 Sep 2013
Last updated
11 Jan 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 38628675

  • 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.

    PubMed 30885692

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing rAAV1-PG9DP in people with HIV Infections, run by International AIDS Vaccine Initiative at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01937455, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2018.

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