Trial Outcomes & Findings for Group B Streptococcus Vaccine in Healthy Females (NCT NCT03807245)
NCT ID: NCT03807245
Last Updated: 2021-02-02
Results Overview
Number of Participants with Treatment Emergent Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
85 days
Results posted on
2021-02-02
Participant Flow
Healthy female participants aged 18 to 40 years were recruited in a Phase 1 unit from January 2019 and the study was completed by October 2019.
Participant milestones
| Measure |
GBS-NN/NN2 With Alhydrogel® 25
GBS-NN/NN2 with Alhydrogel® containing 25 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
|
GBS-NN/NN2 With Alhydrogel® 50
GBS-NN/NN2 with Alhydrogel® containing 50 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
|
Placebo With Alhydrogel®
Placebo (buffer with Alhydrogel®) vaccine administered by intramuscular injection 2 times with 4 weeks apart
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
12
|
|
Overall Study
COMPLETED
|
23
|
24
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Group B Streptococcus Vaccine in Healthy Females
Baseline characteristics by cohort
| Measure |
GBS-NN/NN2 With Alhydrogel® 25
n=24 Participants
GBS-NN/NN2 with Alhydrogel® containing 25 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
|
GBS-NN/NN2 With Alhydrogel® 50
n=24 Participants
GBS-NN/NN2 with Alhydrogel® containing 50 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
|
Placebo With Alhydrogel®
n=12 Participants
Placebo (buffer with Alhydrogel®) vaccine administered by intramuscular injection 2 times with 4 weeks apart
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.8 Years
STANDARD_DEVIATION 5.36 • n=5 Participants
|
30.8 Years
STANDARD_DEVIATION 6.04 • n=7 Participants
|
27.3 Years
STANDARD_DEVIATION 5.53 • n=5 Participants
|
29.7 Years
STANDARD_DEVIATION 5.72 • n=4 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
12 participants
n=5 Participants
|
60 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 85 daysNumber of Participants with Treatment Emergent Adverse Events
Outcome measures
| Measure |
GBS-NN/NN2 With Alhydrogel® 25
n=24 Participants
GBS-NN/NN2 with Alhydrogel® containing 25 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
|
GBS-NN/NN2 With Alhydrogel® 50
n=24 Participants
GBS-NN/NN2 with Alhydrogel® containing 50mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
|
Placebo With Alhydrogel®
n=12 Participants
Placebo (buffer with Alhydrogel®) administered by intramuscular injection 2 times with 4 weeks apart
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
17 Participants
|
15 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 85Adjusted geometric mean concentration (GMC)
Outcome measures
| Measure |
GBS-NN/NN2 With Alhydrogel® 25
n=24 Participants
GBS-NN/NN2 with Alhydrogel® containing 25 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
|
GBS-NN/NN2 With Alhydrogel® 50
n=24 Participants
GBS-NN/NN2 with Alhydrogel® containing 50mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
|
Placebo With Alhydrogel®
n=12 Participants
Placebo (buffer with Alhydrogel®) administered by intramuscular injection 2 times with 4 weeks apart
|
|---|---|---|---|
|
Immunoglobulin(Ig)G Antibody Concentration
GBS-NN
|
15.2 Adjusted GMC mcg/mL
Interval 11.1 to 20.8
|
17.1 Adjusted GMC mcg/mL
Interval 12.5 to 23.4
|
0.115 Adjusted GMC mcg/mL
Interval 0.0746 to 0.177
|
|
Immunoglobulin(Ig)G Antibody Concentration
GBS-NN2
|
24.0 Adjusted GMC mcg/mL
Interval 18.8 to 30.8
|
29.9 Adjusted GMC mcg/mL
Interval 23.4 to 38.3
|
0.154 Adjusted GMC mcg/mL
Interval 0.109 to 0.216
|
SECONDARY outcome
Timeframe: Day 1 to Day 85Geometric mean fold change in antibody concentration from Day 1 to Day 85 for each group.
Outcome measures
| Measure |
GBS-NN/NN2 With Alhydrogel® 25
n=24 Participants
GBS-NN/NN2 with Alhydrogel® containing 25 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
|
GBS-NN/NN2 With Alhydrogel® 50
n=24 Participants
GBS-NN/NN2 with Alhydrogel® containing 50mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
|
Placebo With Alhydrogel®
n=12 Participants
Placebo (buffer with Alhydrogel®) administered by intramuscular injection 2 times with 4 weeks apart
|
|---|---|---|---|
|
Fold Change in Antibody Concentration
GBS-NN
|
127.707 Fold change from Day 1 to Day 85
Interval 79.31 to 205.637
|
131.526 Fold change from Day 1 to Day 85
Interval 93.987 to 184.057
|
0.951 Fold change from Day 1 to Day 85
Interval 0.791 to 1.144
|
|
Fold Change in Antibody Concentration
GBS-NN2
|
169.594 Fold change from Day 1 to Day 85
Interval 104.224 to 275.964
|
211.303 Fold change from Day 1 to Day 85
Interval 140.29 to 318.26
|
0.946 Fold change from Day 1 to Day 85
Interval 0.838 to 1.068
|
SECONDARY outcome
Timeframe: Day 854-fold increase in Immunoglobulin(Ig)G antibody concentration
Outcome measures
| Measure |
GBS-NN/NN2 With Alhydrogel® 25
n=23 Participants
GBS-NN/NN2 with Alhydrogel® containing 25 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
|
GBS-NN/NN2 With Alhydrogel® 50
n=23 Participants
GBS-NN/NN2 with Alhydrogel® containing 50mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
|
Placebo With Alhydrogel®
n=12 Participants
Placebo (buffer with Alhydrogel®) administered by intramuscular injection 2 times with 4 weeks apart
|
|---|---|---|---|
|
Seroconversion Rate
GBS-NN
|
23 Participants
|
23 Participants
|
0 Participants
|
|
Seroconversion Rate
GBS-NN2
|
23 Participants
|
23 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 29 and Day 85Number of participants with Immunoglobulin(Ig)G antibody concentration above thresholds
Outcome measures
| Measure |
GBS-NN/NN2 With Alhydrogel® 25
n=24 Participants
GBS-NN/NN2 with Alhydrogel® containing 25 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
|
GBS-NN/NN2 With Alhydrogel® 50
n=24 Participants
GBS-NN/NN2 with Alhydrogel® containing 50mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
|
Placebo With Alhydrogel®
n=12 Participants
Placebo (buffer with Alhydrogel®) administered by intramuscular injection 2 times with 4 weeks apart
|
|---|---|---|---|
|
Number of Participants With an Immune Response to First and Second Doses
GBS-NN Day 29 increase above 1mcg/mL
|
19 Participants
|
23 Participants
|
0 Participants
|
|
Number of Participants With an Immune Response to First and Second Doses
GBS-NN Day 29 increase above 2mcg/mL
|
19 Participants
|
20 Participants
|
0 Participants
|
|
Number of Participants With an Immune Response to First and Second Doses
GBS-NN Day 29 increase above 4mcg/mL
|
17 Participants
|
17 Participants
|
0 Participants
|
|
Number of Participants With an Immune Response to First and Second Doses
GBS-NN Day 29 increase above 8mcg/mL
|
13 Participants
|
13 Participants
|
0 Participants
|
|
Number of Participants With an Immune Response to First and Second Doses
GBS-NN Day 85 increase above 1mcg/mL
|
23 Participants
|
23 Participants
|
0 Participants
|
|
Number of Participants With an Immune Response to First and Second Doses
GBS-NN Day 85 increase above 2mcg/mL
|
20 Participants
|
23 Participants
|
0 Participants
|
|
Number of Participants With an Immune Response to First and Second Doses
GBS-NN Day 85 increase above 4mcg/mL
|
20 Participants
|
21 Participants
|
0 Participants
|
|
Number of Participants With an Immune Response to First and Second Doses
GBS-NN Day 85 increase above 8mcg/mL
|
18 Participants
|
20 Participants
|
0 Participants
|
|
Number of Participants With an Immune Response to First and Second Doses
GBS-NN2 Day 29 increase above 1mcg/mL
|
20 Participants
|
22 Participants
|
0 Participants
|
|
Number of Participants With an Immune Response to First and Second Doses
GBS-NN2 Day 29 increase above 2mcg/mL
|
18 Participants
|
22 Participants
|
0 Participants
|
|
Number of Participants With an Immune Response to First and Second Doses
GBS-NN2 Day 29 increase above 4mcg/mL
|
17 Participants
|
18 Participants
|
0 Participants
|
|
Number of Participants With an Immune Response to First and Second Doses
GBS-NN2 Day 29 increase above 8mcg/mL
|
16 Participants
|
18 Participants
|
0 Participants
|
|
Number of Participants With an Immune Response to First and Second Doses
GBS-NN2 Day 85 increase above 1mcg/mL
|
23 Participants
|
23 Participants
|
0 Participants
|
|
Number of Participants With an Immune Response to First and Second Doses
GBS-NN2 Day 85 increase above 2mcg/mL
|
22 Participants
|
22 Participants
|
0 Participants
|
|
Number of Participants With an Immune Response to First and Second Doses
GBS-NN2 Day 85 increase above 4mcg/mL
|
20 Participants
|
22 Participants
|
0 Participants
|
|
Number of Participants With an Immune Response to First and Second Doses
GBS-NN2 Day 85 increase above 8mcg/mL
|
18 Participants
|
22 Participants
|
0 Participants
|
Adverse Events
GBS-NN/NN2 With Alhydrogel® 25
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
GBS-NN/NN2 With Alhydrogel® 50
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo With Alhydrogel®
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GBS-NN/NN2 With Alhydrogel® 25
n=24 participants at risk
GBS-NN/NN2 with Alhydrogel® containing 25 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
|
GBS-NN/NN2 With Alhydrogel® 50
n=24 participants at risk
GBS-NN/NN2 with Alhydrogel® containing 50 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
|
Placebo With Alhydrogel®
n=12 participants at risk
Placebo (buffer with Alhydrogel®) administered by intramuscular injection 2 times with 4 weeks apart
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
4.2%
1/24 • 85 days
|
0.00%
0/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/24 • 85 days
|
4.2%
1/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
General disorders
Influenza like illness
|
8.3%
2/24 • 85 days
|
4.2%
1/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Immune system disorders
Allergy to animal
|
4.2%
1/24 • 85 days
|
0.00%
0/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Infections and infestations
Gastroenteritis viral
|
4.2%
1/24 • 85 days
|
0.00%
0/24 • 85 days
|
8.3%
1/12 • 85 days
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/24 • 85 days
|
4.2%
1/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Nervous system disorders
Carpal tunnel syndrome
|
4.2%
1/24 • 85 days
|
0.00%
0/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/24 • 85 days
|
0.00%
0/24 • 85 days
|
8.3%
1/12 • 85 days
|
|
Gastrointestinal disorders
Dyspepsia
|
4.2%
1/24 • 85 days
|
0.00%
0/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24 • 85 days
|
8.3%
2/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24 • 85 days
|
4.2%
1/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
General disorders
Pain
|
0.00%
0/24 • 85 days
|
0.00%
0/24 • 85 days
|
8.3%
1/12 • 85 days
|
|
General disorders
Pyrexia
|
4.2%
1/24 • 85 days
|
0.00%
0/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Infections and infestations
Influenza
|
8.3%
2/24 • 85 days
|
0.00%
0/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Infections and infestations
Lower respiratory tract infection
|
4.2%
1/24 • 85 days
|
0.00%
0/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
3/24 • 85 days
|
8.3%
2/24 • 85 days
|
16.7%
2/12 • 85 days
|
|
Infections and infestations
Pharyngitis
|
4.2%
1/24 • 85 days
|
0.00%
0/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/24 • 85 days
|
4.2%
1/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/24 • 85 days
|
4.2%
1/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Infections and infestations
Urinary tract infection
|
4.2%
1/24 • 85 days
|
4.2%
1/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Infections and infestations
Viral infection
|
0.00%
0/24 • 85 days
|
0.00%
0/24 • 85 days
|
8.3%
1/12 • 85 days
|
|
Infections and infestations
Vulvovaginal candidiasis
|
8.3%
2/24 • 85 days
|
0.00%
0/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
4.2%
1/24 • 85 days
|
0.00%
0/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/24 • 85 days
|
4.2%
1/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
1/24 • 85 days
|
0.00%
0/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.2%
1/24 • 85 days
|
0.00%
0/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/24 • 85 days
|
0.00%
0/24 • 85 days
|
8.3%
1/12 • 85 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/24 • 85 days
|
4.2%
1/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/24 • 85 days
|
0.00%
0/24 • 85 days
|
8.3%
1/12 • 85 days
|
|
Nervous system disorders
Headache
|
37.5%
9/24 • 85 days
|
20.8%
5/24 • 85 days
|
41.7%
5/12 • 85 days
|
|
Nervous system disorders
Lethargy
|
4.2%
1/24 • 85 days
|
4.2%
1/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Nervous system disorders
Migraine
|
0.00%
0/24 • 85 days
|
4.2%
1/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/24 • 85 days
|
4.2%
1/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
12.5%
3/24 • 85 days
|
4.2%
1/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Reproductive system and breast disorders
Hypomenorrhoea
|
0.00%
0/24 • 85 days
|
0.00%
0/24 • 85 days
|
8.3%
1/12 • 85 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • 85 days
|
0.00%
0/24 • 85 days
|
0.00%
0/12 • 85 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/24 • 85 days
|
8.3%
2/24 • 85 days
|
8.3%
1/12 • 85 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place