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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
90
GBS-NN/NN2 bound to alhydrogel as an adjuvant
Normal Saline 0.9 %
University Hospital Ghent - Centrum voor Vaccinologie (CEVAC) department
Ghent, Belgium
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
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
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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