## Protocol Section
### Identification Module
**NCT ID:** NCT00982579

**Acronym:** PedVacc001

**Brief Title:** Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1/2-uninfected Mothers

**Official Title:** An Open Randomized Phase I Study Evaluating Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA.HIVA, Administered to Healthy Infants Born to HIV-1/2-uninfected Mothers

#### Organization Study ID Info
**ID:** PV001
#### Organization
**Class:** OTHER_GOV
**Full Name:** Medical Research Council
### Status Module
#### Completion Date
**Date:** 2011-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-02-03

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-02-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-06

**Type:** ACTUAL

#### Start Date
**Date:** 2009-11

**Status Verified Date:** 2009-09

#### Study First Post Date
**Date:** 2009-09-23
**Type:** ESTIMATED
**Study First Submit Date:** 2009-09-22
**Study First Submit QC Date:** 2009-09-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** European and Developing Countries Clinical Trials Partnership (EDCTP)

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Medical Research Council

#### Responsible Party

**Old Name Title:** Dr. Tomas Hanke

**Old Organization:** Medical Research Council, UK

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Objectives:

Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Gambian infants born to HIV-1/2-uninfected mothers.

Gross impact of MVA.HIVA on the immunogenicity of EPI vaccines (DTwPHib, HepB, PCV-7 and OPV) when administered at 20 weeks (4 weeks after the last EPI vaccines), who have had BCG vaccine within the first 4 weeks of life.

### Conditions Module

**Conditions:**

- HIV-1

- HIV Infections

**Keywords:**

- HIV preventive vaccine

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 48

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Vaccinated at 20 weeks of age (n=24)

**Intervention Names:**

- Biological: MVA.HIVA

**Label:** Vaccinees

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** No experimental vaccine (n=24)

**Label:** Controls

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Vaccinees

**Description:** 1 dose of 5 x 10\^7 pfu of MVA.HIVA administered intramuscularly

**Name:** MVA.HIVA

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Measure:** For safety and reactogenicity: Actively and passively collected data on adverse events

**Time Frame:** Up to 16 weeks after vaccination

#### Secondary Outcomes

**Measure:** For immunity to EPI vaccines: Antibody levels to specific vaccines.

**Time Frame:** 1 week before and 1 week after vaccination

**Measure:** For immunogenicity: Frequency of IFN-γ producing cells determined in ex-vivo (effector) and 10-day cultured (memory) ELISPOT assays after overnight stimulation with pools of HIVA-derived peptides

**Time Frame:** Up to 16 weeks after vaccination

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy infants, 19 weeks of age, with weight for age z-scores within 2 standard deviations of normal.
* Have received all standard EPI immunizations according to national immunization programme.
* Written informed consent by parent.
* Mother HIV-1/2-uninfected.

Exclusion Criteria:

* Acute disease at the time of vaccination (acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory tract infection with or without low-grade febrile illness, i.e. axillary temperature of \<37.5 °C ).
* Axillary temperature of ≥ 37.5 °C at the time of vaccination.
* Any clinically significant abnormal finding on screening from biochemistry or haematology at 19 weeks.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products.
* Presence of any underlying disease that compromises the diagnosis and evaluation of response to the vaccine.
* Invasive bacterial infections (pneumonia, meningitis).
* Any other on-going chronic illness requiring hospital specialist supervision.
* Administration of immunoglobulins and/or any blood products within one month preceding the planned administration of the vaccine candidate.
* Any history of anaphylaxis in reaction to vaccination.
* Research physician's assessment of lack of willingness by parents to participate and comply with all requirements of the protocol, or identification of any factor felt to significantly increase the infant's risk of suffering an adverse outcome.
* Likelihood of travel away from the study area.
* Untreated malaria infection.
* Any other clinical evidence of infection.

**Healthy Volunteers:** True

**Maximum Age:** 3 Days

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Banjul

**Country:** Gambia

**Facility:** Medical Research Council Laboratories, The Gambia

**State:** Fajara

#### Overall Officials

**Official 1:**

**Affiliation:** Medical Research Council

**Name:** Tomas Hanke

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Medical Research Council, The Gambia

**Name:** Katie Flanagan

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Karolinska Institutet

**Name:** Marie Reilly

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Afolabi MO, Ndure J, Drammeh A, Darboe F, Mehedi SR, Rowland-Jones SL, Borthwick N, Black A, Ambler G, John-Stewart GC, Reilly M, Hanke T, Flanagan KL. A phase I randomized clinical trial of candidate human immunodeficiency virus type 1 vaccine MVA.HIVA administered to Gambian infants. PLoS One. 2013 Oct 24;8(10):e78289. doi: 10.1371/journal.pone.0078289. eCollection 2013.

**PMID:** 24205185

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

- ID: D000015229

- Term: Sexually Transmitted Diseases, Viral

- ID: D000012749

- Term: Sexually Transmitted Diseases

- ID: D000016180

- Term: Lentivirus Infections

- ID: D000012192

- Term: Retroviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000007153

- Term: Immunologic Deficiency Syndromes

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18250

- Name: HIV Infections

- Relevance: HIGH

- As Found: HIV Infections

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15558

- Name: Sexually Transmitted Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17933

- Name: Sexually Transmitted Diseases, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M18640

- Name: Lentivirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15026

- Name: Retroviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10199

- Name: Immunologic Deficiency Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015658

- Term: HIV Infections

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
