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

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 1

Locations

Spain

Study Type

Interventional

Intervention

Experimental

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Low risk HIV infection, HIV Seronegativity, HIV Preventive Vaccine

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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
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

Sites / Locations

Hospital Clínic i Provincial de Barcelona
Hospital Universitario Gregorio Marañón

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Main

Arm Description

MVA HIV-B

Outcomes

Primary Outcome Measures

Local adverse event

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

Grade 3 or above systemic adverse event

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

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

Event attributable to vaccine leading to discontinuation

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

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

Secondary Outcome Measures

All grade 1 and 2 adverse events

Antibody responses

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

cellular responses

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

Full Information

NCT ID

NCT01923610

First Posted

August 13, 2013

Last Updated

March 20, 2017

Sponsor

Hospital Clinic of Barcelona

1. Study Identification

Unique Protocol Identification Number

NCT01923610

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

September 2013 (Actual)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

Low risk HIV infection, HIV Seronegativity, HIV Preventive Vaccine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Main

Arm Type

Experimental

Arm Description

MVA HIV-B

Intervention Type

Biological

Intervention Name(s)

Experimental

Intervention Description

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

Primary Outcome Measure Information:

Title

Local adverse event

Description

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

Time Frame

12 weeks

Title

Grade 3 or above systemic adverse event

Description

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

Time Frame

12 weeks

Title

Grade 3 or above other clinical or laboratory adverse event

Description

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

Time Frame

12 weeks

Title

Event attributable to vaccine leading to discontinuation

Description

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

Time Frame

12 weeks

Title

Primary immunogenicity parameters

Description

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

All grade 1 and 2 adverse events

Time Frame

28 days of vaccination

Title

Antibody responses

Description

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

Time Frame

12 weeks

Title

cellular responses

Description

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

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Felipe Garcia, MD

Organizational Affiliation

Hospital Clínic i Provincial de Barcelona

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Clínic i Provincial de Barcelona

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital Universitario Gregorio Marañón

City

Madrid

ZIP/Postal Code

28007

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

29065142

Citation

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. Erratum In: PLoS One. 2018 Apr 10;13(4):e0195915.

Results Reference

derived

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

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