A Study to Evaluate the Safety and Ability of the Vaccine to Induce Antibodies Against the Respiratory Syncytial Virus in Healthy Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02298179
• Date of registration: 19/11/2014
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: A Study to Evaluate the Safety and Ability of the Vaccine to Induce Antibodies Against the Respiratory Syncytial Virus in Healthy Adults
• Scientific title: A Phase 1 Randomized, Observer Blind, Placebo Controlled, Dosage-Escalation Single Center Study to Evaluate the Safety and Immunogenicity of an RSV Fusion Glycoprotein (F) Subunit Vaccine in Healthy Adults
• Date of first enrolment: December 19, 2014
• Target sample size: 288
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02298179
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Healthy males and non-pregnant females 18 to 45 years of age at time of enrollment.

2. Individuals who have given written consent after the nature of the study has been
explained according to local regulatory requirements.

3. Individuals in good health as determined by the outcome of the medical history,
physical examination and clinical judgment of the investigator.

4. Individuals who can comply with the study procedures and are available for follow up.

Exclusion Criteria:

1. Individuals with any severe chronic or acute disease.

2. Individuals with a history of illness or with an ongoing illness that may pose
additional risk to the subject if he/she participates in the study, including the
following:

- History of any chronic respiratory illness, including current diagnosis of asthma
within 2 years, exercise induced wheezing, reactive airway disease, emphysema,
chronic bronchitis, cystic fibrosis or chronic obstructive pulmonary disease
(COPD).

- Any respiratory illness within 7 days prior to receiving the first study
injection.

- Any active pulmonary infection or other inflammatory conditions, even in the
absence of febrile episodes, within 14 days prior to the first study injection.

- Hepatitis B or hepatitis C infection.

3. Individuals who have had a malignancy or lymphoproliferative disorder within the past
5 years.

4. Individuals with known or suspected impairment of the immune system including but not
limited to HIV, autoimmune disorders, immunosuppressive therapy, and diabetes
mellitus.

5. Individuals with any history of progressive or severe neurologic disorder, seizure
disorder or Guillian-Barré syndrome.

6. Individuals with a known bleeding diathesis, or any condition that may be associated
with a prolonged bleeding time.

7. Individuals with a BMI > 35 kg/m2. BMI is to be calculated by the following formula:
subject weight at baseline divided by subject height in meters multiplied by the
subject height in meters. The numerical result will be rounded to the nearest 0.1.

8. Individuals who are allergic to any of the vaccine components, or with a history of
anaphylaxis after vaccination.

9. Individuals who during the 90 days prior to enrollment receive any medications or
other treatments that may adversely affect the immune system such as allergy
injections, immune globulin, interferon, immunomodulators, cytotoxic drugs or other
drugs known to be frequently associated with significant major organ toxicity.

10. Individuals who receive systemic immunosuppressive agents including steroids. Prior
corticosteroid therapy should be discontinued 28 days prior to enrollment. Individuals
using inhaled or topical corticosteroids will be permitted.

11. Receipt or donation of blood or blood products 8 weeks prior to vaccination or planned
receipt or donation during the study period.

12. Individuals participating in any clinical trial with another investigational product
28 days prior to receiving the first study vaccination or intent to participate in
another clinical study at any time during the conduct of this study.

13. Individuals who have received any vaccine 28 days prior to enrollment in this study,
or who plan to receive any non-study vaccines within 28 days of the second dose of
study vaccine.

14. Individuals with any clinically significant abnormal safety laboratory result, as
judged by the investigator.

15. If female, 'of childbearing potential', sexually active and has not used any of the
'acceptable contraceptive methods' for at least two months prior to study entry.

Childbearing potential is defined as status post onset of menarche and not meeting any
of the following conditions: menopausal for at least two years; sterile status after
bilateral tubal ligation for at least one year, immediately after bilateral
oophorectomy or after hysterectomy.

Acceptable methods of birth control are defined as one or more of the following:

- Hormonal contraceptives.

- Barrier each and every time during intercourse.

- Intrauterine device (IUD).

- Monogamous relationship with vasectomized partner. Partner must have been
vasectomized for at least six months prior to subject's study entry.

16. If female subject of childbearing potential and have a positive urine pregnancy test
prior to study vaccinations, or are currently lactating.

17. If female of childbearing potential and sexually active, refusal to use an 'acceptable
contraceptive method' through to three weeks after last study vaccination.

18. Individuals with behavioral or cognitive impairment or psychiatric disease that, in
the opinion of the investigator, may interfere with the subject's ability to
participate in the study.

19. Individuals with a history of drug or alcohol abuse within the past 2 years.

20. Individuals who are acting as study personnel or immediate family members or the
spouse of study personnel.

21. Individuals with a body temperature =38 °C (=100.4?F) within 3 days of intended study
vaccination.

22. Individuals with any condition that, in the opinion of the investigator, would
interfere with the primary study objectives.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Respiratory Syncytial Virus (RSV)

Intervention(s)

Biological: RSV F subunit 90 µg Aluminum hydroxide adjuvant

Biological: RSV F subunit 135 µg Aluminum hydroxide adjuvant

Biological: RSV F subunit 135 µg No adjuvant

Biological: RSV F subunit 90 µg MF59 adjuvant

Drug: Placebo

Biological: RSV F subunit 135 µg MF59 adjuvant

Biological: RSV F subunit 45 µg Aluminum hydroxide adjuvant

Biological: RSV F subunit 45 µg MF59 adjuvant

Biological: RSV F subunit 45 µg No adjuvant

Biological: RSV F subunit 90 µg No adjuvant

Primary Outcome(s)

Number of Subjects With Any Solicited Local Symptoms [Time Frame: From Day 1 (6 hours) to Day 7 after each vaccination]

Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity [Time Frame: From Day 1 (6 hours) through Day 3 after each vaccination]

Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity [Time Frame: From Day 1 (6 hours) to Day 7 after each vaccination]

Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity [Time Frame: From Day 4 through Day 7 after each vaccination]

Number of Subjects With Any Solicited Local Symptoms [Time Frame: From Day 4 through Day 7 after each vaccination]

Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers [Time Frame: At Day 57]

Number of Subjects With Any Solicited Local Symptoms [Time Frame: From Day 1 (6 hour) through Day 3 after each vaccination]

Number of Subjects With Any Solicited Local Symptoms [Time Frame: Within 30 minutes after each vaccination]

Number of Subjects With Serious Adverse Events (SAEs) and Other Significant AE(s) [Time Frame: From study start (Day 1) until study completion (Day 394)]

Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity [Time Frame: Within 30 minutes after each vaccination]

Percentage of Subjects With a = 4-fold Increase in Serum Anti-RSV NAb Titers [Time Frame: At Day 57]

Number of Subjects With Unsolicited Adverse Events (AEs) [Time Frame: From Day 1 to Day 28 after each vaccination]

Secondary Outcome(s)

Geometric Mean Titers (GMTs) of the Serum Total Binding Antibody to Each of the RSV Proteins F, G and N [Time Frame: At Day 1, Day 29, Day 57 and Day 181]

Ratio of RSV F Serum Nab Titers to Each of the RSV F Serum Total Binding Antibody Titers to RSV Proteins F, G and N [Time Frame: At Day 1, Day 29, Day 57 and Day 181]

Percentage of Subjects With a = 4-fold Increase in Serum Total Binding Antibody to Each of the RSV Proteins F, G and N [Time Frame: At Day 29, Day 57 and Day 181]

Percentage of Subjects With a = 4-fold Increase in Serum Anti-RSV NAb Titer [Time Frame: At Day 29 and at Day 181]

Percentage of Subjects With Serum Total Binding Antibody Titers to Each of the RSV Proteins F, G, and N Greater Than the 3rd Quartile of Serum Total Binding Antibody Titers to RSV Protein F at Day 1 [Time Frame: At Day 29, Day 57 and Day 181]

Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers [Time Frame: At Day 1, Day 29 and Day 181]

Percentage of Subjects With Serum Anti-RSV NAb Titers Greater Than the 3rd Quartile of Serum Anti-RSV NAb Titers at Day 1 [Time Frame: At Day 29, Day 57 and Day 181]

Secondary ID(s)

V122_01

2014-000145-69

205219

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/08/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02298179