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Phase 1 Safety and Immunogenicity of Meningococcal Vaccine (HOPS)

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: NCT00678652
Recruitment Status : Completed
First Posted : May 15, 2008
Results First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Meningococcal Infection, Group B
Interventions: Biological: 10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine
Biological: 25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine
Biological: 50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine
Biological: 75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects recruited from CTC database if they have asked to be informed about upcoming studies. Posters//flyers, tv, internet, newspaper ads and word of mouth to recruit healthy subjects. Recruitment may include oral presentations and/or distribution of approved recruiting materials.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine

Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant

10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study

25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine

Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant

25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study

50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine

Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant

50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study

75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine

Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant

75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study


Participant Flow:   Overall Study
    10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine   25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine   50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine   75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
STARTED   9   9   9   9 
COMPLETED   6   9   8   9 
NOT COMPLETED   3   0   1   0 
Protocol Violation                2                0                0                0 
Pregnancy                0                0                1                0 
Relocation                1                0                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine

Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant

10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study

25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine

Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant

25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study

50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine

Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant

50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study

75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine

Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant

75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study

Total Total of all reporting groups

Baseline Measures
   10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine   25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine   50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine   75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   9   9   9   36 
Age, Customized [1] 
[Units: Participants]
Count of Participants
         
18 - 45   9   9   9   9   36 
[1] 18 - 45 years old
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      2  22.2%      3  33.3%      5  55.6%      4  44.4%      14  38.9% 
Male      7  77.8%      6  66.7%      4  44.4%      5  55.6%      22  61.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0%      1  11.1%      1   2.8% 
Not Hispanic or Latino      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      9 100.0%      9 100.0%      9 100.0%      8  88.9%      35  97.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      1  11.1%      0   0.0%      0   0.0%      0   0.0%      1   2.8% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      1  11.1%      0   0.0%      1   2.8% 
Black or African American      7  77.8%      7  77.8%      3  33.3%      5  55.6%      22  61.1% 
White      1  11.1%      2  22.2%      5  55.6%      4  44.4%      12  33.3% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
         
United States   9   9   9   9   36 


  Outcome Measures

1.  Primary:   Bactericidal Absolute Values After Group B Meningococcal 8570 HOPS-G NOMV Vaccine Injections   [ Time Frame: 18 weeks. Days 0, 14, 56, 84, 98 and 126 ]

2.  Primary:   Rate of Seroconversion After the 2nd Dose of 8570 L3-5,7-5 Vaccine   [ Time Frame: 42+7 days (visit 7) ]

3.  Primary:   Rate of Seroconversion After the 3rd Dose of 8570 L3-5, 7-5 Vaccine   [ Time Frame: 84+7 days (visit 11) ]

4.  Secondary:   Total Antibody Response to the Parent Strain of Group B Meningococcus   [ Time Frame: 126 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Paul B. Keiser, M.D.
Organization: Clinical Trials Center, WRAIR
e-mail: noinformation@available.com



Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00678652     History of Changes
Other Study ID Numbers: WRAIR 1395
HSRRB Log A-14553 ( Other Identifier: IRB )
MIDRP AM0035_07_WR ( Other Identifier )
S-15-08 ( Other Identifier: Sponsor )
First Submitted: May 8, 2008
First Posted: May 15, 2008
Results First Submitted: November 1, 2016
Results First Posted: December 18, 2017
Last Update Posted: December 18, 2017