CompletedNCT05782179Updated Sep 5, 2025Results posted

Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants

A Phase 1 interventional study of GBS-NN/NN2 and Placebo in Group B Streptococcal Infections, sponsored by Minervax ApS. Completed at 1 site in Belgium. Open to participants aged 55 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-05.

Sponsored by Minervax ApS · Phase 1, Interventional, and Prevention

Phase: Phase 1
Study type: Interventional
Enrollment: 90
Allocation: Randomized
Ages: 55 Years to 75 Years
Sex: All

Study summary

The study is a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of three doses of GBS NN/NN2 with Alhydrogel® (Recombinant protein vaccine against Group B Streptococcus) in elderly participants aged 55 to 75.Participants will be followed up to 6 months after last vaccination.

Read the detailed description

Sixty (60) healthy older adult participants aged 55 to 75 years will be randomised in two cohorts; 30 obese and/or diabetic participants aged 55 to 75 years will be randomised in two cohorts.

Participants will be involved in the study for approximately one year including screening and safety follow-up.

Eligible participants will be administered a dose of GBS-NN/NN2 or placebo on three occasions: the first dose will be administered on Day 1, followed by the second and third doses 4 and 24 weeks later, respectively.

Conditions studied

Group B Streptococcal Infections

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Streptococcal Infections 155

In context

Streptococcal Infections

155 studies on the registry are indexed under Streptococcal Infections; 15 are open to participants now.

This study's enrollment of 90 is below the median of 250 across 105 interventional studies indexed under Streptococcal Infections.

Browse Streptococcal Infections studies →

Lead sponsor

Minervax ApS is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 55 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Participants aged 55 to 75 years.
Body mass index (BMI) ≥18 and ≤30 kg/m2 for healthy participants, ≥ 30 to ≤45 kg/m2 for obese participants and ≥18 to ≤45 kg/m2 for type 2 diabetic participants.
Able to voluntarily provide written informed consent to participate in the study.
Female participants must be post-menopausal.
Participants capable and willing to follow trial schedule and procedures.

Exclusion criteria

Exclusion Criteria:

Participants who have received a GBS vaccine previously.
Participants with history or presence of significant (as evaluated by the investigator) cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, psychiatric, autoimmune disease or current infection.
NOTE: Patients with type 2 diabetes are to be recruited for Cohort 3 and Cohort 4.
Laboratory values at screening which are deemed by the investigator to be clinically significantly abnormal.
Current or history of drug or alcohol abuse per investigator judgement.
Positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
Participants currently participating in a clinical trial.
Participants receiving an investigational drug, vaccine or device during the 90 days preceding the initial dose in this study.
Any significant illness during the 4 weeks preceding the vaccination visit, per investigator judgement.
Participants with a history of severe allergic reactions after previous vaccination.
Participants who have received any vaccine within 30 days of first IMP administration, or who are planning to receive any vaccine (eg, travel vaccines) up to 30 days after each vaccination.
NOTE: Exceptions could be made for emergency vaccinations (eg, tetanus) or vaccination campaigns (eg, SARS, CoV-2 or influenza) which will be permitted not less than 7 days before or after study vaccination.
Participants receiving immunosuppressive therapy or immunoglobulins in the 6 months prior to screening.
Participants within a 7-day period after an acute infection in the 7 days preceding vaccination, as per investigator judgement, or with fever (oral temperature >37.9°C) in the 72 hours preceding vaccination.
Participants who have received antipyretics/analgesics treatment within 72 hours prior to dosing.
Participants on chronic medications that are likely to affect the assessments specified in the protocol (eg, anticoagulant therapy, systemic steroids).
NOTE: Chronic medications such as antihypertensives, bronchodilators, statins that do not affect the immune system, will be permitted and allowed to continue during the study at the discretion of the investigator. Treatment for diabetes will be continued as required for the diabetic participants recruited. Non-steroidal anti-inflammatory drugs or paracetamol will be permitted for the treatment of headache or other symptoms during the study. Use of over the counter (OTC) vitamins and dietary supplements is allowed.
Participants with skin defects and/or tattoos at the proposed site of vaccine administration.
Donation of blood or blood products within 90 days prior to first study vaccination.
Participants who, in the opinion of the Investigator, are unsuitable for participation in the study.
Involvement in the planning and/or conduct of the study (applies to both Sponsor personnel and/or personnel at the study centre or Clinical Research Organisation [CRO]).

Study design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 90 participants (actual)

Study arms

Experimental
Cohort 1 - Active
Cohort 1 (30 healthy older adult) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
Biological: GBS-NN/NN2
Placebo comparator
Cohort 1 - Placebo
Cohort 1 (30 healthy older adult) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
Biological: Placebo
Experimental
Cohort 2 - Active
Cohort 2 (30 healthy older adult) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
Biological: GBS-NN/NN2
Placebo comparator
Cohort 2 - Placebo
Cohort 2 (30 healthy older adult) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
Biological: Placebo
Experimental
Cohort 3 - Active
Cohort 3 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
Biological: GBS-NN/NN2
Placebo comparator
Cohort 3 - Placebo
Cohort 3 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
Biological: Placebo
Experimental
Cohort 4 - Active
Cohort 4 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
Biological: GBS-NN/NN2
Placebo comparator
Cohort 4 - Placebo
Cohort 4 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
Biological: Placebo

Interventions

BiologicalGBS-NN/NN2
GBS-NN/NN2 bound to alhydrogel as an adjuvant
BiologicalPlacebo
Normal Saline 0.9 %

What researchers measure

Primary outcomes

Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine
* Safety and tolerability as determined by the occurrence of Adverse Events (AEs) consisting of local and systemic reactogenicity within 7 days after vaccination * Unsolicited AEs, including adverse events of special interest (AESIs), Medically attended adverse events (MAAEs) and Serious adverse events (SAEs) within 28 days after each vaccination * AESIs, MAAEs, ARs/SARs leading to withdrawal from the study.
Time frame: Up to 28 days after each vaccination

Secondary outcomes

Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps
Geometric mean antibody concentration in μg/mL for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) to evaluate IgG antibody response to the GBS-NN/NN2 vaccine at Day 197 (principal immunological endpoint).
Time frame: Day 197
Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps
Geometric mean fold increase in antibody concentration for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) to evaluate IgG antibody responses induced by the three vaccine doses, on a 0-, 1- and 6-month regimen, in older adult participants 4 weeks after each vaccination.
Time frame: 4 weeks after each vaccination (Days 29, 57 and 197)
Seroconversion Rate at Any Time Post Vaccination
Seroconversion rate (proportion of participants with a 4-fold increase above baseline - pre dose concentration) at any time post vaccination to assess whether pre existing antibody levels affect the vaccine-induced antibody response.
Time frame: Up to 6 months after last vaccination
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Proportion of participants achieving antibody concentrations for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) above specific thresholds (\>1, \>2, \>4, and \>8 µg/mL) at Days 29, 57, 169, and 197, to evaluate the immune response up to 6 months following the third dose.
Time frame: Up to day 197
Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint)
* Proportion of participants with any SAE from between Day 57 (28 days post second injection) to Day 168 and 28 days after third vaccination (Day 197) up to Day 365. * Proportion of participants with MAAEs, AESIs, ARs/SARs requiring a medical consultation, and or leading to withdrawal from the study from 28 days after third vaccination (Day 197) up to Day 365.
Time frame: Up to day 365

Results

Posted Sep 5, 2025

Participant flow

Overall, 90 participants were enrolled and randomised.

Participant flow — Overall Study
Milestone	Healthy Older Adult : GBS-NN/NN2 50 µg	Healthy Older Adult : GBS-NN/NN2 125 µg	Healthy Older Adult : Placebo	Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg	Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg	Obese and/or Diabetic Older Adult : Placebo
Started	24	24	12	12	12	6
Completed	24	24	10	12	12	6
Not completed	0	0	2	0	0	0
Withdrew: Adverse event	0	0	2	0	0	0

Outcome measures

PrimarySafety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine

* Safety and tolerability as determined by the occurrence of Adverse Events (AEs) consisting of local and systemic reactogenicity within 7 days after vaccination * Unsolicited AEs, including adverse events of special interest (AESIs), Medically attended adverse events (MAAEs) and Serious adverse events (SAEs) within 28 days after each vaccination * AESIs, MAAEs, ARs/SARs leading to withdrawal from the study.

Time frame:: Up to 28 days after each vaccination
Reported as:: Count of participants · Participants

Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine
Participants	Healthy Older Adult : GBS-NN/NN2 50 µg	Healthy Older Adult : GBS-NN/NN2 125 µg	Healthy Older Adult : Placebo	Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg	Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg	Obese and/or Diabetic Older Adult : Placebo
Local Solicited AEs	23	21	5	10	10	2
Systemic Solicited AEs	12	14	6	8	7	4
Unsolicited AEs	17	16	10	9	9	4
AEs leading to withdrawal	0	0	2	0	0	0

SecondaryGeometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps

Geometric mean antibody concentration in μg/mL for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) to evaluate IgG antibody response to the GBS-NN/NN2 vaccine at Day 197 (principal immunological endpoint).

Time frame:: Day 197
Reported as:: Geometric mean · μg/mL

Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps
μg/mL	Healthy Older Adult : GBS-NN/NN2 50 µg	Healthy Older Adult : GBS-NN/NN2 125 µg	Healthy Older Adult : Placebo	Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg	Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg	Obese and/or Diabetic Older Adult : Placebo
Anti-Alp1	13.14 (9.18 to 18.81)	12.34 (9.62 to 15.83)	0.08 (0.03 to 0.21)	8.34 (4.45 to 15.62)	14.17 (7.73 to 25.95)	0.15 (0.06 to 0.35)
Anti-Alp2/3	12.69 (9.26 to 17.39)	17.39 (9.36 to 19.51)	0.04 (0.02 to 0.08)	10.90 (5.52 to 21.52)	14.52 (8.92 to 23.65)	0.09 (0.02 to 0.42)
Anti-AlpC	13.69 (9.82 to 19.09)	11.28 (7.15 to 17.80)	0.04 (0.02 to 0.11)	6.64 (2.64 to 16.68)	14.11 (5.05 to 39.44)	0.10 (0.03 to 0.35)
Anti-Rib	4.76 (2.84 to 7.97)	4.55 (2.78 to 7.46)	0.04 (0.02 to 0.08)	3.67 (1.82 to 7.39)	4.59 (1.58 to 13.37)	0.06 (0.02 to 0.16)

SecondaryGeometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps

Geometric mean fold increase in antibody concentration for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) to evaluate IgG antibody responses induced by the three vaccine doses, on a 0-, 1- and 6-month regimen, in older adult participants 4 weeks after each vaccination.

Time frame:: 4 weeks after each vaccination (Days 29, 57 and 197)
Reported as:: Number · Geometric mean fold ratio

Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps
Geometric mean fold ratio	Healthy Older Adult : GBS-NN/NN2 50 µg	Healthy Older Adult : GBS-NN/NN2 125 µg	Healthy Older Adult : Placebo	Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg	Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg	Obese and/or Diabetic Older Adult : Placebo
Alp1 - Day 29	34.04 (18.65 to 62.13)	24.99 (14.12 to 44.24)	1.04 (0.98 to 1.10)	21.27 (6.47 to 69.87)	43.16 (17.67 to 105.44)	0.78 (0.47 to 1.30)
Alp1- Day 57	70.98 (44.71 to 112.67)	39.71 (25.59 to 61.63)	1.09 (0.99 to 1.19)	32.86 (17.58 to 61.42)	47.89 (25.05 to 91.56)	0.84 (0.63 to 1.11)
Alp1 - Day 197	124.30 (79.84 to 193.52)	106.77 (69.83 to 163.23)	0.85 (0.48 to 1.49)	56.11 (29.99 to 104.99)	114.75 (74.02 to 177.89)	1.46 (0.45 to 4.77)
Alp2/3 - Day 29	40.97 (27.11 to 61.92)	50.32 (29.30 to 86.45)	0.98 (0.90 to 1.07)	20.17 (4.26 to 95.44)	82.64 (30.33 to 225.14)	0.66 (0.24 to 1.79)
Alp2/3 - Day 57	72.60 (51.19 to 102.96)	76.23 (51.23 to 113.42)	1.03 (0.93 to 1.15)	39.29 (16.20 to 95.28)	84.82 (41.61 to 172.89)	0.88 (0.74 to 1.05)
Alp2/3 - Day 197	148.15 (103.14 to 212.79)	204.85 (131.19 to 319.86)	0.69 (0.37 to 1.28)	89.51 (39.87 to 200.93)	205.88 (102.76 to 412.50)	1.09 (0.39 to 3.02)
AlpC - Day 29	59.09 (36.75 to 95.01)	31.75 (16.42 to 61.40)	1.10 (1.02 to 1.17)	29.37 (6.67 to 129.21)	45.62 (16.18 to 128.63)	0.63 (0.24 to 1.71)
AlpC - Day 57	102.29 (65.31 to 160.21)	38.89 (21.45 to 70.50)	1.15 (1.04 to 1.28)	40.66 (15.51 to 106.59)	44.84 (20.39 to 98.61)	0.87 (0.69 to 1.09)
AlpC - Day 197	115.60 (76.71 to 174.19)	114.30 (67.90 to 192.40)	0.45 (0.26 to 0.77)	60.42 (23.95 to 152.45)	91.27 (43.68 to 190.72)	0.95 (0.23 to 3.95)
Rib - Day 29	18.56 (11.85 to 29.09)	26.62 (14.61 to 48.53)	1.03 (0.97 to 1.09)	25.74 (8.03 to 82.57)	20.95 (5.94 to 73.86)	1.00 (0.90 to 1.10)
Rib - Day 57	30.74 (20.83 to 45.37)	34.87 (22.59 to 53.83)	1.09 (1.00 to 1.18)	36.74 (15.40 to 87.64)	24.06 (9.96 to 58.09)	1.10 (0.76 to 1.61)
Rib - Day 197	47.74 (31.94 to 71.35)	69.42 (42.27 to 114.01)	0.68 (0.45 to 1.03)	54.05 (25.53 to 114.40)	37.74 (15.31 to 93.03)	0.58 (0.26 to 1.27)

SecondarySeroconversion Rate at Any Time Post Vaccination

Seroconversion rate (proportion of participants with a 4-fold increase above baseline - pre dose concentration) at any time post vaccination to assess whether pre existing antibody levels affect the vaccine-induced antibody response.

Time frame:: Up to 6 months after last vaccination
Reported as:: Number · participants

Seroconversion Rate at Any Time Post Vaccination
participants	Healthy Older Adult : GBS-NN/NN2 50 µg	Healthy Older Adult : GBS-NN/NN2 125 µg	Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg	Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg	Obese and/or Diabetic Older Adult : Placebo
Anti-Alp1 (µg/mL) - Day 29	22	21	9	11	0
Anti-Alp1 - Day 57	23	24	12	12	0
Anti-Alp1 - Day 169	23	24	11	12	1
Anti-Alp1 - Day 197	24	24	12	12	1
Anti-Alp1 - Day 365	23	24	12	12	1
Anti-Alp2/3 - Day 29	24	23	7	11	0
Anti-Alp2/3 - Day 57	24	24	12	12	0
Anti-Alp2/3 - Day 169	24	24	11	12	1
Anti-Alp2/3 - Day 197	24	24	12	12	1
Anti-Alp2/3 - Day 365	24	24	12	12	0
Anti-AlpC - Day 29	24	21	8	11	0
Anti-AlpC - Day 57	24	24	11	12	0
Anti-AlpC - Day 169	24	20	11	10	2
Anti-AlpC - Day 197	24	24	12	12	2
Anti-AlpC - Day 365	24	22	12	11	2
Anti-Rib - Day 29	22	21	10	10	0
Anti-Rib - Day 57	23	24	11	10	0
Anti-Rib - Day 169	21	21	11	10	0
Anti-Rib - Day 197	23	24	12	11	0
Anti-Rib - Day 365	22	22	12	10	0

SecondaryProportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps

Proportion of participants achieving antibody concentrations for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) above specific thresholds (\>1, \>2, \>4, and \>8 µg/mL) at Days 29, 57, 169, and 197, to evaluate the immune response up to 6 months following the third dose.

Time frame:: Up to day 197
Reported as:: Number · participants

Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
participants	Healthy Older Adult : GBS-NN/NN2 50 µg	Healthy Older Adult : GBS-NN/NN2 125 µg	Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg	Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg
Alp 1 >1 µg/mL - Day 29	19	19	8	10
Alp 1 >1 µg/mL - Day 57	23	23	10	11
Alp 1 >1 µg/mL - Day 169	21	20	9	9
Alp 1 >1 µg/mL - Day 197	23	24	12	12
Alp 1 >2 µg/mL - Day 29	16	16	7	10
Alp 1 >2 µg/mL - Day 57	22	18	9	10
Alp 1 >2 µg/mL - Day 169	18	14	7	7
Alp 1 >2 µg/mL - Day 197	23	24	11	12
Alp 1 >4 µg/mL - Day 29	13	11	7	8
Alp 1 >4 µg/mL - Day 57	17	12	7	8
Alp 1 >4 µg/mL - Day 169	12	7	4	6
Alp 1 >4 µg/mL - Day 197	23	24	10	11
Alp 1 >8 µg/mL - Day 29	8	5	4	5
Alp 1 >8 µg/mL - Day 57	13	8	5	5
Alp 1 >8 µg/mL - Day 169	8	2	1	2
Alp 1 >8 µg/mL - Day 197	19	18	5	8
Alp2/3 >1 µg/mL - Day 29	20	20	8	11
Alp2/3 >1 µg/mL - Day 57	23	21	9	11
Alp2/3 >1 µg/mL - Day 169	20	20	9	12
Alp2/3 >1 µg/mL - Day 197	24	24	12	12
Alp2/3 >2 µg/mL - Day 29	17	17	8	11
Alp2/3 >2 µg/mL - Day 57	20	19	9	10
Alp2/3 >2 µg/mL - Day 169	18	16	8	9
Alp2/3 >2 µg/mL - Day 197	23	24	12	12
Alp2/3 >4 µg/mL - Day 29	12	12	7	8
Alp2/3 >4 µg/mL - Day 57	17	16	9	8
Alp2/3 >4 µg/mL - Day 169	11	11	7	6
Alp2/3 >4 µg/mL - Day 197	23	21	10	11
Alp2/3 >8 µg/mL - Day 29	6	5	4	5
Alp2/3 >8 µg/mL - Day 57	9	7	6	5
Alp2/3 >8 µg/mL - Day 169	5	4	3	2
Alp2/3 >8 µg/mL - Day 197	19	18	8	10
Rib >1 µg/mL - Day 29	18	18	8	8
Rib >1 µg/mL - Day 57	20	18	9	8
Rib >1 µg/mL - Day 169	18	14	8	6
Rib >1 µg/mL - Day 197	22	20	11	10
Rib >2 µg/mL - Day 29	13	11	6	8
Rib >2 µg/mL - Day 57	18	16	8	7
Rib >2 µg/mL - Day 169	11	12	6	4
Rib >2 µg/mL - Day 197	19	20	9	9
Rib >4 µg/mL - Day 29	7	9	4	6
Rib >4 µg/mL - Day 57	11	11	5	5
Rib >4 µg/mL - Day 169	6	4	3	3
Rib >4 µg/mL - Day 197	16	16	6	7
Rib >8 µg/mL - Day 29	3	2	2	3
Rib >8 µg/mL - Day 57	5	1	3	3
Rib >8 µg/mL - Day 169	3	1	1	2
Rib >8 µg/mL - Day 197	9	9	4	5
AlpC >1 µg/mL - Day 29	22	17	8	9
AlpC >1 µg/mL - Day 57	23	18	10	10
AlpC >1 µg/mL - Day 169	22	19	9	9
AlpC >1 µg/mL - Day 197	24	24	11	11
AlpC >2 µg/mL - Day 29	21	15	7	9
AlpC >2 µg/mL - Day 57	21	16	9	9
AlpC >2 µg/mL - Day 169	21	18	6	8
AlpC >2 µg/mL - Day 197	23	22	10	10
AlpC >4 µg/mL - Day 29	15	12	6	8
AlpC >4 µg/mL - Day 57	20	12	6	9
AlpC >4 µg/mL - Day 169	15	10	4	6
AlpC >4 µg/mL - Day 157	23	20	6	10
AlpC >8 µg/mL - Day 29	11	7	5	7
AlpC >8 µg/mL - Day 57	19	9	5	7
AlpC >8 µg/mL - Day 169	5	5	3	5
AlpC >8 µg/mL - Day 197	21	17	6	9

SecondaryLong-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint)

* Proportion of participants with any SAE from between Day 57 (28 days post second injection) to Day 168 and 28 days after third vaccination (Day 197) up to Day 365. * Proportion of participants with MAAEs, AESIs, ARs/SARs requiring a medical consultation, and or leading to withdrawal from the study from 28 days after third vaccination (Day 197) up to Day 365.

Time frame:: Up to day 365
Reported as:: Number · participants

Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint)
participants	Healthy Older Adult : GBS-NN/NN2 50 µg	Healthy Older Adult : GBS-NN/NN2 125 µg	Healthy Older Adult : Placebo	Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg	Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg	Obese and/or Diabetic Older Adult : Placebo
SAE from Day 57 to Day 168	0	0	1	0	0	0
SAE from Day 197 to Day 365	0	1	1	0	0	0
MAAEs from Day 197 up to Day 365	12	9	2	1	5	2
AESIs from Day 197 up to Day 365	0	0	1	0	0	0
ARs/SARs from Day 197 up to Day 365	0	0	0	0	0	0

Adverse events

Collected over All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Healthy Older Adult : GBS-NN/NN2 50 µg	0/24 (0%)	1/24 (4.2%)	17/24 (70.8%)
Healthy Older Adult : GBS-NN/NN2 125 µg	0/24 (0%)	1/24 (4.2%)	16/24 (66.7%)
Healthy Older Adult : Placebo	0/12 (0%)	2/12 (16.7%)	10/12 (83.3%)
Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg	0/12 (0%)	1/12 (8.3%)	9/12 (75%)
Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg	0/12 (0%)	0/12 (0%)	9/12 (75%)
Obese and/or Diabetic Older Adult : Placebo	0/6 (0%)	0/6 (0%)	4/6 (66.7%)

Most frequent serious events

Most frequent serious events
Event	Healthy Older Adult : GBS-NN/NN2 50 µg	Healthy Older Adult : GBS-NN/NN2 125 µg	Healthy Older Adult : Placebo	Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg	Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg	Obese and/or Diabetic Older Adult : Placebo
CholelithiasisHepatobiliary disorders	0/24	0/24	1/12	0/12	0/12	0/6
AppendicitisInfections and infestations	0/24	0/24	1/12	0/12	0/12	0/6
Spinal stenosisMusculoskeletal and connective tissue disorders	0/24	0/24	1/12	0/12	0/12	0/6
Joint range of motion decreasedMusculoskeletal and connective tissue disorders	0/24	0/24	0/12	1/12	0/12	0/6
Cervicobrachial syndromeNervous system disorders	1/24	0/24	0/12	0/12	0/12	0/6
Coronary artery diseaseCardiac disorders	0/24	1/24	0/12	0/12	0/12	0/6
PneumoniaInfections and infestations	0/24	1/24	0/12	0/12	0/12	0/6

Most frequent other events

Showing 10 of 84

Most frequent other events
Event	Healthy Older Adult : GBS-NN/NN2 50 µg	Healthy Older Adult : GBS-NN/NN2 125 µg	Healthy Older Adult : Placebo	Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg	Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg	Obese and/or Diabetic Older Adult : Placebo
Injection site haemorrhageGeneral disorders	0/24	5/24	2/12	1/12	0/12	1/6
NasopharyngitisInfections and infestations	2/24	5/24	0/12	2/12	2/12	0/6
Vitreous floatersEye disorders	0/24	0/24	0/12	0/12	0/12	1/6
FatigueGeneral disorders	0/24	1/24	0/12	0/12	2/12	0/6
Tooth infectionInfections and infestations	0/24	0/24	2/12	0/12	0/12	0/6
Upper respiratory tract infectionInfections and infestations	0/24	0/24	1/12	2/12	0/12	0/6
Post-traumatic painInjury, poisoning and procedural complications	0/24	0/24	1/12	0/12	0/12	1/6
Traumatic haematomaInjury, poisoning and procedural complications	0/24	0/24	0/12	0/12	0/12	1/6
Type 2 diabetes mellitusMetabolism and nutrition disorders	0/24	0/24	0/12	0/12	0/12	1/6
Oropharyngeal painRespiratory, thoracic and mediastinal disorders	3/24	2/24	0/12	2/12	0/12	0/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Healthy Older Adult : GBS-NN/NN2 50 µg	Healthy Older Adult : GBS-NN/NN2 125 µg	Healthy Older Adult : Placebo	Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg	Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg	Obese and/or Diabetic Older Adult : Placebo	Total
Mean	65.2 ± 5.4	64.5 ± 5.5	65.8 ± 5.0	64.5 ± 6.0	65.4 ± 4.6	65.8 ± 1.3	65.1 ± 5.1

Sex: Female, Male
Sex: Female, Male(Participants)	Healthy Older Adult : GBS-NN/NN2 50 µg	Healthy Older Adult : GBS-NN/NN2 125 µg	Healthy Older Adult : Placebo	Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg	Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg	Obese and/or Diabetic Older Adult : Placebo	Total
Female	11	11	4	7	8	4	45
Male	13	13	8	5	4	2	45

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Healthy Older Adult : GBS-NN/NN2 50 µg	Healthy Older Adult : GBS-NN/NN2 125 µg	Healthy Older Adult : Placebo	Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg	Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg	Obese and/or Diabetic Older Adult : Placebo	Total
Hispanic or Latino	0	0	0	0	0	0	0
Not Hispanic or Latino	24	24	12	12	12	6	90
Unknown or Not Reported	0	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Healthy Older Adult : GBS-NN/NN2 50 µg	Healthy Older Adult : GBS-NN/NN2 125 µg	Healthy Older Adult : Placebo	Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg	Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg	Obese and/or Diabetic Older Adult : Placebo	Total
American Indian or Alaska Native	0	0	0	0	0	0	0
Asian	1	0	0	0	0	0	1
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0
Black or African American	0	0	0	0	0	0	0
White	23	24	12	12	12	6	89
More than one race	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0	0

Height
Height(cm)	Healthy Older Adult : GBS-NN/NN2 50 µg	Healthy Older Adult : GBS-NN/NN2 125 µg	Healthy Older Adult : Placebo	Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg	Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg	Obese and/or Diabetic Older Adult : Placebo	Total
Mean	167.81 ± 10.50	168.98 ± 7.58	167.12 ± 7.85	171.88 ± 9.36	169.15 ± 11.67	172.00 ± 14.49	169.03 ± 9.65

Weight
Weight(Kg)	Healthy Older Adult : GBS-NN/NN2 50 µg	Healthy Older Adult : GBS-NN/NN2 125 µg	Healthy Older Adult : Placebo	Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg	Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg	Obese and/or Diabetic Older Adult : Placebo	Total
Mean	70.98 ± 13.16	70.65 ± 7.45	68.88 ± 11.75	95.68 ± 12.54	95.38 ± 14.09	95.07 ± 11.91	78.76 ± 16.41

Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)	Healthy Older Adult : GBS-NN/NN2 50 µg	Healthy Older Adult : GBS-NN/NN2 125 µg	Healthy Older Adult : Placebo	Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg	Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg	Obese and/or Diabetic Older Adult : Placebo	Total
Mean	24.993 ± 2.537	24.808 ± 2.854	24.668 ± 3.856	32.262 ± 1.584	33.323 ± 3.340	32.437 ± 5.123	27.476 ± 4.772

Study locations

1 site

University Hospital Ghent - Centrum voor Vaccinologie (CEVAC) department
Ghent, 9000, Belgium

References and documents

Study documents

Study protocol · May 11, 2023
Statistical analysis plan · Apr 23, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05782179
Lead sponsor: Minervax ApS
Collaborators: IQVIA Pty Ltd
Responsible party: Sponsor
First posted: Mar 23, 2023
Start date: Mar 1, 2023
Primary completion: Dec 14, 2023
Completion: May 23, 2024
Results posted: Sep 5, 2025
Last update: Sep 5, 2025

Study contacts

Geoff Kitson

study director · gkitson@propharmapartners.uk.com

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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