Recombinant CMV gB Vaccine in Postpartum Women
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00125502 |
Recruitment Status :
Completed
First Posted : August 1, 2005
Last Update Posted : September 20, 2011
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Condition or disease | Intervention/treatment | Phase |
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Cytomegalovirus Infections | Biological: CMV gB vaccine Drug: MF59 adjuvant Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 464 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial of Recombinant CMV gB Vaccine in Postpartum Women |
Study Start Date : | August 1999 |
Actual Primary Completion Date : | June 2007 |
Actual Study Completion Date : | January 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: I
n=200; 20 micrograms gB with MF59
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Biological: CMV gB vaccine
CMV gB is combined with a novel adjuvant, MF59, a proprietary oil-in-water emulsion, administered at 0, 1, and 6 months. Drug: MF59 adjuvant Oil-in-water emulsion |
Placebo Comparator: II
n=200; placebo (normal saline)
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Drug: Placebo
Normal saline solution |
- Time to CMV infection. [ Time Frame: From initial vaccine to final study visit. ]
- Rate of CMV infection in CMV gB vaccine and placebo recipients. [ Time Frame: From initial vaccine to final study visit. ]
- Rate of congenital CMV infection in offspring of the immunized women. [ Time Frame: From initial vaccine to final study visit. ]
- Rate of local and systemic reactions and adverse events. [ Time Frame: Duration of study. ]
- Peak levels of antibody to CMV gB and neutralizing antibody and decline in antibody levels over time. [ Time Frame: 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. [ Time Frame: From 3 months post-third dose of vaccine to study termination. ]

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Ages Eligible for Study: | 14 Years to 40 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125502
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294-3293 | |
University of Alabama at Tuscaloosa | |
Tuscaloosa, Alabama, United States, 35487 |
Principal Investigator: | Robert F Pass, MD | University of Alabama at Birmingham |
Responsible Party: | Robert Pass, MD, Professor of Pediatrics, University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00125502 |
Other Study ID Numbers: |
99-038 U01AI063565 ( U.S. NIH Grant/Contract ) sanofi pasteur CMC00 |
First Posted: | August 1, 2005 Key Record Dates |
Last Update Posted: | September 20, 2011 |
Last Verified: | September 2011 |
CMV, Cytomegalovirus, vaccine, women, postpartum |
Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases Infections |