gB/MF59 Vaccine in Preventing Cytomegalovirus Infection in Healthy Adolescent Females

NCT00133497 | Completed Phase 2

• 1 other identifier: 04-039
• Study Type: interventional
• Target: 409
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this research study is to test the safety of and the body's response to an experimental cytomegalovirus (CMV) vaccine (called gB/MF59 vaccine). Participants will include approximately 400 healthy females, ages 12-17, recruited from adolescent clinics at Cincinnati Children's Hospital Medical Center, Vanderbilt University Medical Center, Baylor College of Medicine, University of Texas School of Public Health, Houston, and the University of Texas Medical Branch at Galveston. Participants will receive 3 doses of vaccine or placebo (saltwater) on a 0, 1, and 6 month schedule. Study procedures will include blood and urine samples. Participants will complete a diary recording temperatures and any side effects experienced. Subjects will be involved in study related procedures for up to 31 months.

Conditions

Cytomegalovirus Infections

Keywords

cytomegalovirus, vaccine, women, children, parent protocol

Outcome Measures

Primary Outcomes (2)

• Efficacy: systemic cytomegalovirus (CMV) infection, defined by the detection of CMV in the urine or blood, which will be evaluated by CMV detection by polymerase chain reaction (PCR).

  Study Day 0, Month 1, Month 2, Month 6, Month 7 and every 3 months after Month 7.

• Safety: incidence of local and systemic reactions, as determined by self-reported assessments using a memory aid, adverse events (AEs) and serious adverse events (SAEs).

  Local and systemic reactions within 7 days of vaccination; adverse events (AEs) within the 30 day period after vaccination; serious adverse events (SAEs) observed any time throughout the duration of study.

Secondary Outcomes (3)

• Efficacy: CMV infections defined as seroconversion to nonvaccine CMV antigens or identification of CMV in the blood or urine.

  Specimens collected every 3 months.

• Immunologic: CMV antibody measurements by CMV neutralization, enzyme-linked immunosorbent assay (ELISA), and CMV glycoprotein B (gB) assay.

  Study Day 0, Month 6, Month 7 and every 3 months after Month 7.

• Duration and magnitude of CMV replication in the urine and blood as determined from specimens.

  Obtained monthly for 4 months and then every other month for 8 months after identification of CMV infection.

Study Arms (2)

20 mcg CMV gB + MF59

EXPERIMENTAL

200 subjects will receive vaccine CMV gB + MF59.

Biological: MF-59; Biological: CMV gB vaccine

Saline

PLACEBO COMPARATOR

200 subjects will receive saline placebo.

Drug: Placebo

Interventions

MF-59 BIOLOGICAL

Microfluoridized adjuvant 59 (MF59).

20 mcg CMV gB + MF59

Placebo DRUG

0.5 mL of saline placebo.

Saline

CMV gB vaccine BIOLOGICAL

CMV glycoprotein B (gB) delivered as 20 mcg in 0.5 mL of vaccine.

20 mcg CMV gB + MF59

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects must be willing and able to provide written informed assent prior to study enrollment; parent(s) or legal guardian must provide written informed consent prior to study enrollment.
• Subjects must be female and be 12 to 17 years at time of screening.
• Subjects must be willing to consider participation in the experimental cytomegalovirus (CMV) vaccine portion of the study which is 31-months in duration and must not be planning to relocate from the study area.
• Subjects must be using or willing to consider using effective methods of birth control. This includes abstinence or if sexually active using an effective method of birth control (e.g., oral contraceptives; diaphragm or condom in combination with contraceptive jelly; cream or foam; intrauterine contraceptive device; Depo-Provera®; skin patch; vaginal ring or cervical cap) for 30 days prior to vaccination and must agree to continue such precautions for 3 months after completion of the vaccination series.
• Subjects who are of childbearing potential must be willing to have a urine or serum pregnancy test within 24 hours before vaccination. The results will need to be negative to enroll in the vaccine study.
• Subject is willing and able to provide written informed assent prior to study enrollment; parent(s) or legal guardian provides written informed consent prior to study enrollment.
• Subject is female and 12 to 17 years at time of screening.
• Subject is available for the 31-month duration of the study (7 months on the study and 24 months of follow-up beginning 1 month after the last injection) and is not planning to relocate from the study area.
• Subject must agree to practice abstinence, or if sexually active must be using an effective method of birth control (e.g., oral contraceptives; diaphragm or condom in combination with contraceptive jelly; cream or foam; intrauterine contraceptive device; Depo-Provera®; skin patch; vaginal ring or cervical cap) for 30 days prior to vaccination and must agree to continue such precautions for 3 months after completion of the vaccination series.
• Subject of child bearing potential has a negative urine or serum pregnancy test within 24 hours of vaccination.
• Subject is willing and able to comply with the requirements of the protocol (e.g., completion of the memory aid, return for follow-up visits, accessible by phone and not planning on moving from the study area).
• Subjects must be willing and able to provide written informed assent prior to study enrollment; parent(s) or legal guardian must provide written informed consent prior to study enrollment.
• Subject is positive for antibodies to CMV detected by enzyme-linked immunosorbent assay (ELISA) using a commercial CMV antibody assay screen.
• Subjects must be willing and able to comply with the requirements of the protocol (e.g., completion of the visits, accessible by phone and not planning on moving from the study area).

You may not qualify if:

• Receipt of blood and/or blood products in the past 3 months
• Known to be pregnant or lactating
• Planning to become pregnant during the first 8 months of the study (Months 0-8);
• Known previous infection with cytomegalovirus (CMV);
• Previously received a CMV vaccine;
• History of allergic reactions to any component of the study vaccine;
• History of malignancy or have a confirmed or suspected immunodeficient condition, such as human immunodeficiency virus (HIV) infection;
• History of current acute or chronic autoimmune disease;
• History of ongoing clinically significant illness (diabetes, pulmonary, cardiovascular, hepatic or renal functional abnormality) as determined by medical history;
• History of any neurologic disorders or seizures, with the exception of febrile seizures during childhood;
• Presently receiving or history of receiving any medications or treatments that affect the immune system such as immune globulin, interferon, immunomodulators, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable) in the past 6 months. Inhaled and topical corticosteroids will be allowed;
• History of depression not controlled with current drug therapy or involving institutionalization;
• History of schizophrenia or psychosis;
• History of suicide attempt;
• Active substance or alcohol abuse;

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (5)

Cincinnati Children's Hospital Medical Center - Infectious Diseases

Cincinnati, Ohio, 45229-3026, United States

Location

Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center

Nashville, Tennessee, 37232-2573, United States

Location

The University of Texas Medical Branch - Sealy Center for Vaccine Development (SCVD)

Galveston, Texas, 77555-1121, United States

Location

The University of Texas Health Science Center - Pediatrics

Houston, Texas, 77030-1501, United States

Location

Baylor College of Medicine - Molecular Virology and Microbiology

Houston, Texas, 77030-3411, United States

Location

Related Publications (1)

• Hu X, Karthigeyan KP, Herbek S, Valencia SM, Jenks JA, Webster H, Miller IG, Connors M, Pollara J, Andy C, Gerber LM, Walter EB, Edwards KM, Bernstein DI, Hou J, Koch M, Panther L, Carfi A, Wu K, Permar SR. Human Cytomegalovirus mRNA-1647 Vaccine Candidate Elicits Potent and Broad Neutralization and Higher Antibody-Dependent Cellular Cytotoxicity Responses Than the gB/MF59 Vaccine. J Infect Dis. 2024 Aug 16;230(2):455-466. doi: 10.1093/infdis/jiad593.

  PMID: 38324766 DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2005
• First Posted: August 23, 2005
• Study Start: June 1, 2006
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 6, 2017

Record last verified: 2013-09

Locations

US (5)