AzTrials
AzTrials

HIV InfectionsPhase 1NCT01923610

Safety and Immunological Response of a Boosting Dose of MVA-B in Healthy Volunteers After 4 Years of Receiving MVA-B

A Phase 1 study testing Experimental in people with HIV Infections, run by Hospital Clinic of Barcelona at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

24 healthy male and female volunteers who are at low risk of HIV infection and entered into the RISVAC02 study and were randomly allocated to receive 3 intramuscular injections of MVA-B at weeks 0, 4 and 16 will receive a boosting dose 4 years thereafter. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
Experimental
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesSpain
Study dates
Sep 2013to Sep 2014
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • male or female
  • age between 18 and 55 years on the day of screening
  • available for follow-up for the duration of the study (52 weeks from screening)
  • able to give written informed consent
  • at low risk of HIV and willing to remain so for the duration of the study low risk of HIV infection defined as: no history of injecting drug use in the previous ten years no gonorrhoea or syphilis in the last six months no high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months no unprotected anal intercourse in the last six months no unprotected vaginal intercourse outside a relationship with a regular known/presumed HIV negative partner in the last six months
  • willing to undergo a HIV test
Show all 9Show fewer
  • willing to undergo a genital infection screen
  • if heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable contraceptive; IUCD; consistent record with condoms if using these; physiological or anatomical sterility in self or partner) from 14 days prior to the first vaccination until 4 months after the last, and willing to undergo urine pregnancy tests prior to each vaccination
  • if heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination

Who cannot join

  • positive for hepatitis B surface antigen, hepatitis C antibody, antibody responses to vaccinia or serology indicating active syphilis requiring treatment
  • pregnant or lactating
  • clinically relevant abnormality on history or examination including history of grand-mal epilepsy, severe eczema, immunodeficiency or use of immunosuppressives in preceding 3 months
  • receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment
  • receipt of blood products or immunoglobin within 4 months of screening
  • participation in another trial of a medicinal product, completed less than 30 days prior to enrolment
Show all 11Show fewer
  • history of severe local or general reaction to vaccination defined as local: extensive, indurated redness and swelling involving most of the front-lateral thigh or the major circumference of the arm, not resolving within 72 hours general: fever >= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal
  • HIV 1/2 positive or indeterminate on screening
  • positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
  • grade 1 routine laboratory parameters
  • unlikely to comply with protocol

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Hospital Clínic i Provincial de Barcelona

    Barcelona, Catalonia, 08036

  • Hospital Universitario Gregorio Marañón

    Madrid, Madrid, 28007

Other trials in Spain

About this study

24 healthy male and female volunteers who are at low risk of HIV infection and entered into the RISVAC02 study and were randomly allocated to receive 3 intramuscular injections of MVA-B at weeks 0, 4 and 16 will receive a boosting dose 4 years thereafter.

Participants will attend one of two clinical centres on at least 5 occasions over 16 weeks. These visits will comprise:

Read more
  • Screening
  • Trial entry and boosting immunisation
  • Early follow-up after immunisation
  • Follow-up x 2 including the final visit Participants will have blood and urine collected, and receive 1 immunisation. They will be counselled prior to and following a HIV test, and given health education on prevention of sexually transmitted infections including HIV. T

The two centres which participate are:

  • Hospital Clinic, Barcelona and
  • Hospital Gregorio Marañón, Madrid The primary objective is to explore the safety and immunogenicity of MVA-B.
Conditions
HIV Infections
Being tested
Experimental
Keywords
Low risk HIV infection, HIV Seronegativity, HIV Preventive Vaccine
Medical subject headings
HIV Infections

What participants receive

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

  • ExperimentalBiological

    Biological/Vaccine: MVA-B Modified Pox virus, strain MVA clade -B (expressing HIV-1 Bx08gp120 and IIIB gagpolnef)

    -~ 1 x 10e8 pfu/ml 3 immunisations at week 0, 4 and 16

Study groups in NCT01923610
Study groupRoleWhat they receive
MainExperimentalMVA HIV-B
Receives: Biological: Experimental

What is being measured

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

  1. Local adverse event

    Grade 3 or above local adverse event (pain, cutaneous reactions including induration)

    Measured: 12 weeks

  2. Grade 3 or above systemic adverse event

    Grade 3 or above systemic adverse event (temperature, chills, headache, nausea, vomiting, malaise, and myalgia)

    Measured: 12 weeks

  3. Grade 3 or above other clinical or laboratory adverse event

    Grade 3 or above other clinical or laboratory adverse event confirmed at examination or on repeat testing respectively

    Measured: 12 weeks

  4. Event attributable to vaccine leading to discontinuation

    Any event attributable to vaccine leading to discontinuation of the immunisation regimen

    Measured: 12 weeks

  5. Primary immunogenicity parameters

    The primary immunogenicity parameters will be quantitative or present/absent, and are cellular responses - CD8/CD4+ T cell responses (ELISPOT) at week 2, 4 and 12 following the immunisations

    Measured: 12 weeks

Secondary outcomes (3)

  1. All grade 1 and 2 adverse events

    Measured: 28 days of vaccination

  2. Antibody responses

    • binding titration to the construct MVAB
    • binding titration to and neutralisation of vaccinia

    Measured: 12 weeks

  3. cellular responses

    • CD8/CD4+ T cell responses (ELISPOT) at week 0
    • intracellular cytokine analysis at week 0, 2, 4 and 12

    Measured: 12 weeks

Timeline

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

  1. First posted15 Aug 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionSep 2014
  4. Study completionSep 2014

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01923610
Sponsor's protocol ID
RisVac02 boost
Status last verified
Mar 2017
First submitted
13 Aug 2013
Last updated
21 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • Guardo AC, Gomez CE, Diaz-Brito V, Pich J, Arnaiz JA, Perdiguero B, Garcia-Arriaza J, Gonzalez N, Sorzano COS, Jimenez L, Jimenez JL, Munoz-Fernandez MA, Gatell JM, Alcami J, Esteban M, Lopez Bernaldo de Quiros JC, Garcia F, Plana M; RISVAC02boost study. Safety and vaccine-induced HIV-1 immune responses in healthy volunteers following a late MVA-B boost 4 years after the last immunization. PLoS One. 2017 Oct 24;12(10):e0186602. doi: 10.1371/journal.pone.0186602. eCollection 2017.

    PubMed 29065142

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Experimental in people with HIV Infections, run by Hospital Clinic of Barcelona at 2 sites in Spain.

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 9 inclusion and 11 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: finished, as of the sponsor's last update on 21 Mar 2017. 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 Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Local adverse event (time frame: 12 weeks). The study lists 5 primary outcomes in all. 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 NCT01923610, which also lists 1 linked publication.

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 21 Mar 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in