Trial Outcomes & Findings for MRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022) (COMPLETED) (NCT NCT00857311)

Last Updated: 2015-08-25

Results Overview

Serious and non serious clinical (systemic and injection-site AEs), and laboratory AEs were collected. Systemic and laboratory AEs reflect any unfavorable \& unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. Vaccine-related AEs are those determined by the investigator to be possibly, probably, or definitely related to the administration of the vaccine.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

17 participants

Primary outcome timeframe

up to Week 78 (52 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs

Results posted on

2015-08-25

Participant Flow

All participants had to be at low risk of acquiring human immunodeficiency virus (HIV) infection, and had to meet a number of laboratory criteria. They could not have received treatment for hepatitis C virus infection in the 3 months prior to enrollment and must not anticipate to begin treatment with in 1 year after enrollment.

Participant milestones

Participant milestones
Measure	MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose Participants administered MRKAd5 HIV-1 gag vaccine 1x10\^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.	Placebo Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
Overall Study STARTED	9	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose Participants administered MRKAd5 HIV-1 gag vaccine 1x10\^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.	MRKAd5 HIV-1 Gag Vaccine 1x10^10 vp/Dose Participants were to be administered MRKAd5 HIV-1 gag 1x10\^10 vp/dose (V520) on Day 1, Week 4, and Week 26. Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in the group MRKAd5 HIV-1 gag 1x10\^10 vp/dose.	Placebo Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.	Open Label Tetanus and Diptheria Toxoids Adsorbed Participants were to be administered open label tetanus and diptheria toxoids adsorbed (Td) at Day 1 only. Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in this group.
Overall Study Lost to Follow-up	1	0	0	0

Baseline Characteristics

MRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022) (COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose n=9 Participants Participants administered MRKAd5 HIV-1 gag vaccine 1x10\^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.	MRKAd5 HIV-1 Gag Vaccine 1x10^10 vp/Dose Participants were to be administered MRKAd5 HIV-1 gag 1x10\^10 vp/dose (V520) on Day 1, Week 4, and Week 26. Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in the group MRKAd5 HIV-1 gag 1x10\^10 vp/dose.	Placebo n=8 Participants Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.	Open Label Tetanus and Diptheria Toxoids Adsorbed Participants were to be administered open label tetanus and diptheria toxoids adsorbed (Td) at Day 1 only. Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in this group.	Total n=17 Participants Total of all reporting groups
Age, Customized	41.4 years n=5 Participants	—	39.3 years n=5 Participants	—	40.4 years n=21 Participants
Gender Female	5 participants n=5 Participants	—	4 participants n=5 Participants	—	9 participants n=21 Participants
Gender Male	4 participants n=5 Participants	—	4 participants n=5 Participants	—	8 participants n=21 Participants
Region of Enrollment United States	9 participants n=5 Participants	—	8 participants n=5 Participants	—	17 participants n=21 Participants

PRIMARY outcome

Timeframe: up to Week 78 (52 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs

Outcome measures

Outcome measures
Measure	MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose n=9 Participants Participants administered MRKAd5 HIV-1 gag vaccine 1x10\^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.	Placebo n=8 Participants Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE) With non-serious vaccine-related (VR) clinical AEs	5 Participants	1 Participants
Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE) ---With non-serious VR systemic AEs	3 Participants	1 Participants
Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE) ---With non-serious VR injection-site AEs	3 Participants	1 Participants
Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE) With serious VR clinical AEs	0 Participants	0 Participants
Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE) ---With serious VR systemic AEs	0 Participants	0 Participants
Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE) ---With serious VR injection-site AEs	0 Participants	0 Participants
Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE) With non-serious VR laboratory AEs	2 Participants	0 Participants
Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE) With serious VR laboratory AEs	0 Participants	0 Participants
Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE) discontinued due to non-serious VR clinical AE	0 Participants	0 Participants
Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE) discontinued due to serious VR clinical AE	0 Participants	0 Participants
Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE) discontinued due to VR non-serious laboratory AE	0 Participants	0 Participants
Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE) discontinued due to VR serious laboratory AE	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to Week 260 (234 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs

Adverse experiences collected include serious and non serious systemic AEs, injection-site AEs, and laboratory AEs. Systemic and laboratory AEs include any unfavorable \& unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to 5 days after any vaccine dose.

Outcome measures

Outcome measures
Measure	MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose n=9 Participants Participants administered MRKAd5 HIV-1 gag vaccine 1x10\^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.	Placebo n=8 Participants Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
Number of Participants With Systemic and Laboratory Adverse Events (AE) With serious systemic AEs	2 Participants	2 Participants
Number of Participants With Systemic and Laboratory Adverse Events (AE) With non-serious injection-site AEs	3 Participants	1 Participants
Number of Participants With Systemic and Laboratory Adverse Events (AE) With serious injection-site AEs	0 Participants	0 Participants
Number of Participants With Systemic and Laboratory Adverse Events (AE) With non-serious laboratory AEs	4 Participants	1 Participants
Number of Participants With Systemic and Laboratory Adverse Events (AE) With serious laboratory AEs	0 Participants	0 Participants
Number of Participants With Systemic and Laboratory Adverse Events (AE) With non-serious systemic AEs	8 Participants	6 Participants

SECONDARY outcome

Timeframe: Week 30 (4 weeks after boost injection)

Population: No analysis was performed.

Participants expressing HIV antigens (gag) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10\^6 peripheral blood mononuclear cells (SFC per million PBMCs). No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00857311) proved it was not efficacious.

Outcome measures

Outcome data not reported

Adverse Events

MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose n=9 participants at risk Participants administered MRKAd5 HIV-1 gag vaccine 1x10\^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.	Placebo n=8 participants at risk Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
Infections and infestations Hepatitis C	0.00% 0/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	12.5% 1/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Injury, poisoning and procedural complications Multiple fractures	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Psychiatric disorders Alcohol abuse	0.00% 0/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	12.5% 1/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee As this study is part of a multicenter trial, publications derived from this study should include input from the principal investigator, his/her colleagues, the other investigators in this trial, and SPONSOR personnel. The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. SPONSOR review can be expedited to meet publication guidelines.
Publication restrictions are in place

Restriction type: OTHER

Measure	MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose n=9 participants at risk Participants administered MRKAd5 HIV-1 gag vaccine 1x10\^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.	Placebo n=8 participants at risk Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
Cardiac disorders Palpitations	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Eye disorders Eye oedema	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Gastrointestinal disorders Diarrhoea	33.3% 3/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	12.5% 1/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Gastrointestinal disorders Haemorrhoids	0.00% 0/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	12.5% 1/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Gastrointestinal disorders Nausea	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	12.5% 1/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Gastrointestinal disorders Vomiting	22.2% 2/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	12.5% 1/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
General disorders Adverse drug reaction	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
General disorders Asthenia	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
General disorders Chest pain	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
General disorders Chills	22.2% 2/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	12.5% 1/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
General disorders Fatigue	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	12.5% 1/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
General disorders Feeling hot	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
General disorders Injection Site Erythema	22.2% 2/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
General disorders Injection Site Pain	33.3% 3/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	12.5% 1/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
General disorders Oedema peripheral	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
General disorders Pain	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	12.5% 1/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
General disorders Pyrexia	33.3% 3/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	12.5% 1/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
General disorders Thirst	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Infections and infestations Cystitis	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Infections and infestations Nasopharyngitis	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Injury, poisoning and procedural complications Joint sprain	0.00% 0/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	12.5% 1/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Injury, poisoning and procedural complications Laceration	0.00% 0/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	12.5% 1/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Injury, poisoning and procedural complications Procedural pain	0.00% 0/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	12.5% 1/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Investigations Alkaline phosphatase increased	0.00% 0/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	12.5% 1/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Investigations Aspartate aminotransferase increased	33.3% 3/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Investigations Haemoglobin decreased	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Musculoskeletal and connective tissue disorders Myalgia	22.2% 2/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Musculoskeletal and connective tissue disorders Pain in extremity	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Nervous system disorders Dizziness	22.2% 2/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Nervous system disorders Headache	22.2% 2/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	12.5% 1/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Nervous system disorders Sciatica	0.00% 0/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	12.5% 1/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Psychiatric disorders Alcohol abuse	0.00% 0/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	12.5% 1/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Psychiatric disorders Dependence	0.00% 0/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	12.5% 1/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Psychiatric disorders Depression	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Respiratory, thoracic and mediastinal disorders Nasal congestion	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	12.5% 1/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Skin and subcutaneous tissue disorders Acne	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Skin and subcutaneous tissue disorders Pruritus	11.1% 1/9 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).	0.00% 0/8 • Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).