Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients

Bavarian Nordic581 enrolled

Overview

The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations. Subjects will receive two vaccinations

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

581

Conditions

HIV Infections

Interventions

IMVAMUNE (MVA-BN)BIOLOGICAL

2 immunizations, four weeks apart: 1 x 10E8 TCID50, subcutaneous

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

* Genders eligible for Study: Both * Age: between 18 and 55 years * Healthy volunteers are accepted Inclusion Criteria: * Subjects tested positive for HIV-1 infection (HIV-infected subjects). * Subjects that are tested negative for HIV (Healthy subjects). * Either on stable antiretroviral therapy or not on antiretroviral therapy. * CD4 cells \> = 200 - 750/µl. * Subjects must be in good general health except for HIV infection. * Women must not be pregnant and use an acceptable method of contraception. Exclusion Criteria: * Impairment of immunologic function (other than HIV infection). * History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure. * Uncontrolled serious infection. * History of or active autoimmune disease. * History or clinical manifestation of clinically significant and severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders. * History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before the age of 50 years. * High risk of developing a myocardial infarction or coronary death. * History of intravenous drug abuse (within the last 12 months). * Known allergy to egg or aminoglycoside (gentamicin). * History of anaphylaxis or severe allergic reaction. * Subjects undergoing treatment for tuberculosis infection or disease. * Chronic administration of systemic immuno-suppressants.

Locations (36)

Outcomes

Primary Outcomes

Serious Adverse Events

Incidence, relationship and intensity of any Serious Adverse Event (SAE)

Time frame: within 32 weeks

Secondary Outcomes

Related Grade >=3 Adverse Events

Incidence of any Grade 3 or higher adverse drug reaction (missing, unknown, not evaluable, possibly, probably, or definitely related) to the study vaccine

Time frame: within 29 days after any vaccination

Solicited Local Adverse Events

Incidence and intensity of solicited local AEs (pain, erythema, swelling). Percentages based on subjects with at least one completed diary card.

Time frame: within 8 days after any vaccination

Solicited General Adverse Events

Incidence of solicited general AEs (increased body temperature, headache, myalgia, chills, nausea, and fatigue): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.

Time frame: within 8 days after any vaccination

Unsolicited Adverse Events: Incidence

Incidence of any unsolicited adverse events

Time frame: within 29 days after any vaccination

Unsolicited Adverse Events: Intensity

Occurrence of unsolicited adverse events by Intensity

Time frame: within 29 days after any vaccination

Unsolicited Adverse Events: Relationship to Vaccination

Occurrence of unsolicited adverse events by relationship to study vaccine

Time frame: within 29 days after any vaccination

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Alabama Vaccine Research Clinic; University of Alabama at Birmingham

Birmingham, Alabama, United States

Health for Life Clinic, PLLC

Little Rock, Arkansas, United States

Providence Clinical Research

Burbank, California, United States

Northern California Research

Carmichael, California, United States

CSI Clinical Trials, Inc.

Fountain Valley, California, United States

AltaMed Health Services

Los Angeles, California, United States

Alta Bates Summit Medical Center, East Bay AIDS Center

Oakland, California, United States

Benchmark Clinical Research

San Francisco, California, United States

Clinical Research of West Florida

Clearwater, Florida, United States

Consultive Medicine

Daytona Beach, Florida, United States

...and 26 more locations

CD4+ T-cell Counts

Median CD4+ T-cell counts over time

Time frame: within 32 weeks

CD8+ T-cell Counts

Median CD8+ T-cell counts over time

Time frame: within 32 weeks

Viral Load

Viral load (HIV-1 RNA levels) over time

Time frame: within 32 weeks

PRNT Seroconversion Rate

Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.

Time frame: within 32 weeks

PRNT GMT

Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.

Time frame: within 32 weeks

ELISA Seroconversion Rate

Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.

Time frame: within 32 weeks

ELISA GMT

Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.

Time frame: within 32 weeks

ELISPOT IFN-γ: Response Rate

Response rate based on number of subjects with response in an interferon gamma (IFN-γ) ELISPOT assay. Response is defined as the appearance of a signal in subjects that had no signal at Baseline or a relative increase by a factor of ≥1.7 compared to Baseline in subjects that had a signal at Baseline. Percentages based on number of subjects with data available.

Time frame: within 32 weeks

ELISPOT IFN-γ: SFU

Median number of interferon gamma (IFN-γ) secreting peripheral blood mononuclear cells (PBMC) in response to stimulation with MVA-BN detected by ELISPOT assay.

Time frame: within 32 weeks