Recombinant CMV gB Vaccine in Postpartum Women

NCT00125502 | Completed Phase 2 DMC

• 3 other identifiers: 99-038U01AI063565sanofi pasteur CMC00
• Study Type: interventional
• Target: 464
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if a new cytomegalovirus (CMV) vaccine (CMV gB/MF59) can safely prevent mothers from catching CMV infection between pregnancies. This study includes 464 women, ages 14-40 years, who delivered a newborn infant within 12 months prior to the study. Participants must live within the Birmingham metropolitan area or the Tuscaloosa county area and they cannot have had CMV infection previously. CMV vaccine or placebo (substance containing no medication) will be given at 3 study visits. Participants fill out diary cards for 7 days after each vaccination. Blood samples will be collected. Urine samples will be collected several times and pregnancy tests will be performed. Participants who tested positive for CMV will have urine, vaginal swab, and saliva specimens collected. Each participant will be followed for 3 years after the third dose of vaccine. Infants born to participants in the study will be checked for CMV infection.

Conditions

Cytomegalovirus Infections

Keywords

CMV, Cytomegalovirus, vaccine, women, postpartum

Outcome Measures

Primary Outcomes (1)

• Time to CMV infection.

  From initial vaccine to final study visit.

Secondary Outcomes (5)

• Rate of CMV infection in CMV gB vaccine and placebo recipients.

  From initial vaccine to final study visit.

• Rate of congenital CMV infection in offspring of the immunized women.

  From initial vaccine to final study visit.

• Rate of local and systemic reactions and adverse events.

  Duration of study.

• Peak levels of antibody to CMV gB and neutralizing antibody and decline in antibody levels over time.

  2 weeks post third dose of vaccine and decline over time up to 3 years post-third dose of vaccine.

• Lymphocyte proliferation response to gB.

  From 3 months post-third dose of vaccine to study termination.

Study Arms (2)

I

EXPERIMENTAL

n=200; 20 micrograms gB with MF59

Biological: CMV gB vaccine; Drug: MF59 adjuvant

II

PLACEBO COMPARATOR

n=200; placebo (normal saline)

Drug: Placebo

Interventions

CMV gB vaccine BIOLOGICAL

CMV gB is combined with a novel adjuvant, MF59, a proprietary oil-in-water emulsion, administered at 0, 1, and 6 months.

I

MF59 adjuvant DRUG

Oil-in-water emulsion

I

Placebo DRUG

Normal saline solution

II

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Mothers, 14 to 40 years of age (inclusive), who have delivered a newborn infant within the previous 12 months, reside within the Birmingham metropolitan area or the Tuscaloosa county area, and sign an informed consent form following a detailed explanation of the study.
• Cytomegalovirus (CMV) seronegative as determined by the Axsym® System CMV IgG antibody assay (Abbott Diagnostics) performed within 14 weeks prior to the first immunization.
• In good health as judged by medical history obtained by patient interview and physical examination.
• Willing to participate with 4 follow-up visits per year for 3 years after the third dose of vaccine.
• Volunteers must be willing to use an effective means of contraception of their choice from the first dose of vaccine up to 2 months after the third dose of the vaccine.
• Methods that were considered effective for the purposes of this clinical trial included any hormonal contraceptive, double barrier methods and abstinence.

You may not qualify if:

• Known maternal immune disorder such as HIV infection, collagen vascular disease, immune deficiency, or chronic disease requiring treatment with immunosuppressive medication.
• Chronic disease such as diabetes, sickle cell disease, heart disease, fibromyalgia, arthritis or asthma requiring medication.
• Patients with a diagnosis of asthma or past asthma were allowed to enroll if they did not currently take medication for asthma and were off asthma medication and free from asthma symptoms for at least 2 years. Patients with mild to moderate essential hypertension on medication were allowed if their blood pressure was controlled within the normal range for at least one month.
• Positive rapid test for HIV antibody. All subjects were tested for HIV antibody using a rapid serologic test at the time of enrollment beginning with protocol version 1.7. Prior to that only subjects who had a history of a negative screening test for HIV during their most recent pregnancy were included. Subjects given HIV rapid serologic tests in this study were provided pre-test counseling before the test was performed and post-test counseling when the subject was informed of the test results. This counseling is provided by the study nurses according to CDC guidelines \[Centers for Disease Control and Prevention. Revised Guidelines for HIV Counseling, Testing and Referral and Revised Recommendations for HIV Screening of Pregnant Women. Subjects who are eligible for this study were considered very unlikely to be HIV positive because almost all adults who are HIV positive are also CMV positive and almost all potential enrollees will have received HIV screening during their recent pregnancy.
• Maternal sterilization procedure planned in the postpartum period.
• Current use of steroids or other immunosuppressive medications.
• Maternal drug or alcohol abuse.
• Mothers who are nursing their infants.
• Participation in a clinical trial of another investigational vaccine or drug, if they have received the investigational drug or vaccine within 6 months prior to enrollment date for this trial.
• A history of anaphylaxis or serious vaccine reactions.
• Previous receipt of CMV vaccine.
• Receipt of blood products within 3 months prior to study enrollment.

Sponsors & Collaborators

• Robert Pass, MD: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• MCM Vaccines B.V.: collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3293, United States

Location

University of Alabama at Tuscaloosa

Tuscaloosa, Alabama, 35487, United States

Location

Related Publications (1)

• Pass RF, Zhang C, Evans A, Simpson T, Andrews W, Huang ML, Corey L, Hill J, Davis E, Flanigan C, Cloud G. Vaccine prevention of maternal cytomegalovirus infection. N Engl J Med. 2009 Mar 19;360(12):1191-9. doi: 10.1056/NEJMoa0804749.

  PMID: 19297572 DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Robert F Pass, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: July 29, 2005
• First Posted: August 1, 2005
• Study Start: August 1, 1999
• Primary Completion: June 1, 2007
• Study Completion: January 1, 2010
• Last Updated: September 20, 2011

Record last verified: 2011-09

Locations

US (2)