Phase 2 N=509 Randomized Quadruple-blind Prevention

A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women

Respiratory Syncytial Virus Infections

Bottom Line

View on ClinicalTrials.gov: NCT04138056 ↗

Enrolled (actual)

509

Serious AEs

0.4%

Results posted

Dec 2022

Primary outcome: Primary: Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] — 5.9; 5; 5.8; 5.9 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: RSVPreF3 formulation 3 (Biological); RSVPreF3 formulation 2 (Biological); Boostrix-ex-US (Biological); Boostrix-US (Biological); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: GlaxoSmithKline
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study]	5.9; 5; 5.8; 5.9; 0; 51.5	—
PRIMARY Percentage of Subjects With Any Solicited General AEs [Primary Study]	40.6; 39.6; 37.9; 32.4; 38.4; 23.8	—
PRIMARY Percentage of Subjects With Any Unsolicited AEs [Primary Study]	38.6; 34.7; 33; 37.3; 32.4	—
PRIMARY Number of Subjects With Any SAEs [Primary Study]	0; 0; 0; 0; 0	—
PRIMARY Percentage of Subjects With Any Solicited Local AEs [Extension Study]	17.9; 10.3; 8.7; 14.6; 2.3; 87.2	—
PRIMARY Percentage of Subjects Any Solicited General AEs [Extension Period]	25.6; 33.3; 37; 46.3; 34.1; 10.3	—
PRIMARY Percentage of Subjects With Any Unsolicited AEs [Extension Period]	18; 20; 20; 29; 20	—
PRIMARY Number of Subjects With Any SAEs [Extension Period]	0; 0; 0; 1; 0	—
PRIMARY RSV A Neutralizing Antibody Geometric Mean Titers (GMTs) at Screening [Primary Study]	875; 1022; 1135; 771; 1050	—
PRIMARY RSV A Neutralizing Antibody GMTs at Day 8 [Primary Study]	14166; 14285; 10185; 10590; 783	—
PRIMARY RSV A Neutralizing Antibody GMTs at Day 31 [Primary Study]	9836; 11038; 9214; 8739; 845	—
PRIMARY RSV PreF3 IgG Antibody Geometric Mean Concentration (GMCs) at Screening [Primary Study]	6611; 6751; 7449; 6172; 6454	—
PRIMARY RSV PreF3 IgG GMCs at Day 8 [Primary Study]	156568; 146708; 101662; 118670; 5780	—
PRIMARY RSV PreF3 IgG GMCs at Day 31 [Primary Study]	101813; 106082; 86273; 88938; 6149	—
SECONDARY Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study]	6; 4.1; 5.9; 2; 0; 5.9	—
SECONDARY Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study]	36; 36.7; 39.2; 29.4; 34.7; 45.1	—
SECONDARY Percentage of Subjects With Any Unsolicited AEs by Each Boostrix Formulation [Primary Study]	38; 36.7; 39.2; 43.1; 33.3; 39.2	—
SECONDARY Number of Subjects With Any SAEs by Each Boostrix Formulation [Primary Study]	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Subjects With Any SAEs From 1st Vaccination to Day 181 [Primary Study]	1; 0; 0; 0; 0	—
SECONDARY Number of Subjects With Any SAEs From 1st Vaccination to Day 181 by Each Boostrix Formulation [Primary Study]	1; 0; 0; 0; 0; 0	—
SECONDARY Number of Subjects With Any SAEs From 2nd Vaccination to Day 181 Post 2nd Vaccination [Extension Period]	0; 0; 0; 1; 0	—
SECONDARY RSV A Neutralizing GMTs at Screening by Each Boostrix Formulation [Primary Study]	777; 1009; 989; 777; 956; 981	—
SECONDARY RSV A Neutralizing GMTs at Day 8 by Each Boostrix Formulation [Primary Study]	14523; 15458; 10677; 11128; 698; 13818	—
SECONDARY RSV A Neutralizing GMTs at Day 31 by Each Boostrix Formulation [Primary Study]	9838; 10800; 8754; 8141; 767; 9834	—
SECONDARY RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study]	2034; 2869; 3086; 2200; 675; 2014	—
SECONDARY RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study]	2027; 2889; 2885; 2302; 759	—
SECONDARY RSV A Neutralizing GMTs at Day 31 Post 2nd Vaccination [Extension Study]	3892; 5071; 4779; 4920; 8200	—
SECONDARY RSV PreF3 IgG GMCs at Screening by Each Boostrix Formulation [Primary Study]	6240; 6524; 7237; 6106; 5907; 6987	—
SECONDARY RSV PreF3 IgG GMCs at Day 8 by Each Boostrix Formulation [Primary Study]	155721; 143104; 100064; 123475; 5523; 157403	—
SECONDARY RSV PreF3 IgG GMCs at Day 31 by Each Boostrix Formulation [Primary Study]	94254; 95113; 84509; 81915; 5600; 109978	—
SECONDARY RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study]	18832; 20894; 23189; 20720; 5014; 18127	—
SECONDARY RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study]	18570; 20605; 23102; 21152; 5540	—
SECONDARY RSV PreF3 IgG GMCs at Day 31 Post 2nd Vaccination [Extension Study]	41399; 42943; 43977; 45680; 86934	—
SECONDARY Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study]	7.39; 7.64; 6.65; 7.55; 5.66; 7.17	—
SECONDARY Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]	57.36; 54.95; 79.16; 43.76; 36.98; 44.99	—
SECONDARY Diphtheria (Anti-D) GMC at Screening by Each Boostrix Formulation [Primary Study]	0.26; 0.27; 0.23; 0.46; 0.55; 0.58	—
SECONDARY Diphtheria (Anti-D) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]	1.3; 1.18; 1.76; 2.11; 2.2; 3.29	—
SECONDARY Tetanus (Anti-T) GMCs at Screening by Each Boostrix Formulation [Primary Study]	1.14; 1.1; 0.88; 1.35; 1.56; 1.68	—
SECONDARY Tetanus (Anti-T) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]	5.57; 5.3; 6.74; 6.09; 6.27; 8.32	—
SECONDARY Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening [Primary Study]	7.47; 6.56; 6.90; 31.9; 31.9; 28.6	—
SECONDARY Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 [Primary Study]	50.10; 45.08; 59.51; 210.3; 192.9; 265.6	—
SECONDARY Diphtheria (Anti-D) GMCs at Screening [Primary Study]	0.35; 0.39; 0.36	—
SECONDARY Diphtheria (Anti-D) GMCs at Day 31 [Primary Study]	1.65; 1.59; 2.42	—
SECONDARY Tetanus (Anti-T) GMCs at Screening [Primary Study]	1.24; 1.31; 1.22	—
SECONDARY Tetanus (Anti-T) GMCs at Day 31 [Primary Study]	5.83; 5.76; 7.49	—

Summary

The purpose of this study is to evaluate the safety, ability of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) to generate an immune response and the degree to which the vaccine can cause side effects, when administered alone and in combination with Boostrix vaccine in healthy non-pregnant women 18-45 years of age. Two dose levels of RSVPreF3 and 2 Boostrix [Diphtheria, Tetanus and acellular Pertussis (dTpa) vaccine] formulations (US and ex-US) will be evaluated. A 2nd dose of RSVPreF3 will be administered in an extension of the study to assess the durability of the immune response after the first dose vaccination, and to assess the safety and immunogenicity following a second dose vaccination of the RSVPreF3 maternal vaccine.

Eligibility Criteria

Inclusion Criteria

Primary study

Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written or witnessed/thumb printed informed consent obtained from the subject prior to performance of any study specific procedure.
Healthy female subjects; as established by medical history and clinical examination, aged 18 to 45 years at the time of the 1st vaccination;
Female subjects of childbearing potential may be enrolled in the study, if the subject:
has practiced adequate contraception for 30 days prior to primary vaccination, and
has a negative pregnancy test on the day of primary vaccination, and
has agreed to continue adequate contraception for 90 days after completion of the vaccination.
No local condition precluding injection in both left and right deltoid muscles.

Extension study

Completed primary study and received 1st dose of a study vaccine.
Written or witnessed/thumb printed informed consent obtained from the subject prior to performance of any study specific procedure to the study extension.

All subjects must satisfy ALL the following criteria:

Subjects who can and will comply with the requirements of the protocol.
Female subjects remain healthy; as established by medical history and clinical examination, aged 18 to 45 years at the time of the 1st vaccination;
Female subjects of childbearing potential are eligible for the extension, if the subject:
has practiced adequate contraception for 30 days prior to 2nd vaccination
has a negative pregnancy test with results available on the day of 2nd vaccination
has agreed to continue adequate contraception for 90 days after completion of the 2nd vaccination.

Exclusion Criteria

Primary study

Medical conditions

History of any reaction/hypersensitivity likely to be exacerbated by any vaccines' component;
Any confirmed/suspected immunosuppressive/immunodeficient condition, based on medical history and physical examination;
Hypersensitivity to latex;
Major congenital defects;
Acute/chronic clinically significant pulmonary, cardiovascular, hepatic/renal functional abnormality;
Significant/uncontrolled psychiatric illness;
Recurrent history/uncontrolled neurological disorders/seizures;
Documented HIV-positive subject;
History of/current autoimmune disease;
Body mass index (BMI)>40 kg/m^2;
Any clinically significant hematological parameter and/or biochemical laboratory abnormality.
Any other clinical condition that might pose additional risk to the subject due to participation in the study.

Prior/Concomitant therapy

Use of any investigational/non-registered product other than the study vaccines during the period starting 30 days before 1st vaccination, or planned use during the study;
Administration of long-acting immune-modifying drugs at any time during the study;
Administration of immunoglobulins and/or any blood products/plasma derivatives during the period starting 3 months before the 1st vaccination or planned administration during the study;
Chronic administration of immunosuppressants/other immune-modifying drugs during the period starting 3 months prior to 1st vaccine dose(s). For corticosteroids, this will mean prednisone ≥5 mg/day, or equivalent. Inhaled and topical steroids are allowed;
Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after study 1st vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before/after study vaccination;
Administration of a vaccine containing diphtheria, tetanus/pertussis antigens/diphtheria and tetanus toxoids within the previous 5 years;
Previous experimental vaccination against RSV;

Prior/Concurrent clinical study experience • Concurrently participating in another clinical study, at any time during the study, in which the subject has been/will be exposed to an

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Data sourced from ClinicalTrials.gov (NCT04138056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.