A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018)
CompletedPhase 3Results postedLast updated 5 May 2022
What this trial tests
Phase 3 trial testing V114 in Pneumococcal Infections in 302 participants. Completed in 17 January 2020.
18 and older, any sex, with Pneumococcal Infections. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 1Primary· Up to 5 days after Vaccination 1 (Up to Day 5)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs consist of redness/erythema, swelling, and tenderness/pain. The 95% confidence interval (CI) were based on the exact binomial method proposed by Clopper and Pearson.
Injection site erythema
Group
Value
95% CI
V114
4.6
1.9 – 9.3
Prevnar 13™
3.3
1.1 – 7.6
Injection site pain
Group
Value
95% CI
V114
57.2
49.0 – 65.2
Prevnar 13™
51.3
43.0 – 59.6
Injection site swelling
Group
Value
95% CI
V114
11.8
7.2 – 18.1
Prevnar 13™
4.0
1.5 – 8.5
Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 1Primary· Up to 14 days after Vaccination 1 (Up to Day 14)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs consist of muscle pain (myalgia), joint pain (arthralgia), headache, and tiredness (fatigue). The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
Arthralgia
Group
Value
95% CI
V114
3.3
1.1 – 7.5
Prevnar 13™
4.0
1.5 – 8.5
Fatigue
Group
Value
95% CI
V114
20.4
14.3 – 27.7
Prevnar 13™
13.3
8.3 – 19.8
Headache
Group
Value
95% CI
V114
13.2
8.2 – 19.6
Prevnar 13™
9.3
5.2 – 15.2
Myalgia
Group
Value
95% CI
V114
12.5
7.7 – 18.8
Prevnar 13™
9.3
5.2 – 15.2
Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 1Primary· Day 1 up to 8 weeks after Vaccination 1 (Up to Week 8)
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
Group
Value
95% CI
V114
0
0.0 – 2.4
Prevnar 13™
0
0.0 – 2.4
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1Primary· Day 30
Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo. Sera from participants was used to measure geometric mean titer (GMT) of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the Multiplexed Opsonophagocytic Assay (MOPA). This assay reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing, as determined by comparison to assay background controls. The 95% CIs
Serotype 1
Group
Value
95% CI
V114
238.8
173.1 – 329.3
Prevnar 13™
200.9
142.7 – 282.7
Serotype 3
Group
Value
95% CI
V114
116.8
94.9 – 143.7
Prevnar 13™
72.3
58.6 – 89.2
Serotype 4
Group
Value
95% CI
V114
824.0
618.8 – 1097.2
Prevnar 13™
1465.5
1154.5 – 1860.3
Serotype 5
Group
Value
95% CI
V114
336.7
242.4 – 467.7
Prevnar 13™
276.7
197.9 – 386.7
Serotype 6A
Group
Value
95% CI
V114
6421.0
4890.4 – 8430.7
Prevnar 13™
5645.1
4278.9 – 7447.4
Serotype 6B
Group
Value
95% CI
V114
4772.9
3628.3 – 6278.7
Prevnar 13™
3554.0
2751.0 – 4591.4
Serotype 7F
Group
Value
95% CI
V114
6085.8
4871.6 – 7602.8
Prevnar 13™
6144.3
4982.8 – 7576.6
Serotype 9V
Group
Value
95% CI
V114
2836.3
2311.5 – 3480.4
Prevnar 13™
2133.9
1721.8 – 2644.5
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1Primary· Day 30
The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex electrochemiluminescence (ECL) using the pneumococcal electrochemiluminescence (PnECL) v2.0 assay, based on the Meso-Scale Discovery technology, which employs disposable multi-spot microtiter plates. The 95% CIs were derived by exponentiating the CIs of the mean of the natural l
Serotype 1
Group
Value
95% CI
V114
3.16
2.48 – 4.01
Prevnar 13™
4.27
3.31 – 5.50
Serotype 3
Group
Value
95% CI
V114
0.57
0.48 – 0.68
Prevnar 13™
0.50
0.41 – 0.60
Serotype 4
Group
Value
95% CI
V114
1.14
0.90 – 1.44
Prevnar 13™
2.00
1.56 – 2.55
Serotype 5
Group
Value
95% CI
V114
2.38
1.89 – 3.01
Prevnar 13™
2.03
1.56 – 2.64
Serotype 6A
Group
Value
95% CI
V114
5.13
3.73 – 7.04
Prevnar 13™
4.91
3.49 – 6.91
Serotype 6B
Group
Value
95% CI
V114
7.17
5.34 – 9.63
Prevnar 13™
5.23
3.73 – 7.35
Serotype 7F
Group
Value
95% CI
V114
2.61
2.00 – 3.41
Prevnar 13™
3.74
2.91 – 4.81
Serotype 9V
Group
Value
95% CI
V114
3.35
2.71 – 4.14
Prevnar 13™
3.55
2.77 – 4.56
Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 2Secondary· Up to 5 days after Vaccination 2 (Up to Day 61)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs consist of redness/erythema, swelling, and tenderness/pain. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
Injection site erythema
Group
Value
95% CI
V114
10.0
5.7 – 16.0
Prevnar 13™
12.2
7.4 – 18.5
Injection site pain
Group
Value
95% CI
V114
53.3
45.0 – 61.5
Prevnar 13™
61.5
53.1 – 69.4
Injection site swelling
Group
Value
95% CI
V114
20.0
13.9 – 27.3
Prevnar 13™
29.1
21.9 – 37.1
Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 2Secondary· Up to 14 days after Vaccination 2 (Up to Day 70)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs consist of muscle pain (myalgia), joint pain (arthralgia), headache, and tiredness (fatigue). The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
Arthralgia
Group
Value
95% CI
V114
2.7
0.7 – 6.7
Prevnar 13™
1.4
0.2 – 4.8
Fatigue
Group
Value
95% CI
V114
12.7
7.8 – 19.1
Prevnar 13™
10.8
6.3 – 17.0
Headache
Group
Value
95% CI
V114
8.7
4.7 – 14.4
Prevnar 13™
8.8
4.8 – 14.6
Myalgia
Group
Value
95% CI
V114
11.3
6.7 – 17.5
Prevnar 13™
12.2
7.4 – 18.5
Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 2Secondary· From Week 8 up to Month 6
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
Group
Value
95% CI
V114
0
0.0 – 2.4
Prevnar 13™
0
0.0 – 2.5
Geometric Mean Titer of Serotype-specific OPA After Vaccination 2Secondary· Week 12
Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo. Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the MOPA. The MOPA reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing, as determined by comparison to assay background controls. The 95% CIs were derived by exponentiating the CIs of the mean of the natu
Serotype 1
Group
Value
95% CI
V114
212.0
160.5 – 280.2
Prevnar 13™
154.0
111.6 – 212.4
Serotype 3
Group
Value
95% CI
V114
102.8
83.0 – 127.2
Prevnar 13™
96.6
79.5 – 117.4
Serotype 4
Group
Value
95% CI
V114
915.4
722.9 – 1159.1
Prevnar 13™
984.7
772.1 – 1255.7
Serotype 5
Group
Value
95% CI
V114
418.1
312.1 – 560.3
Prevnar 13™
274.5
199.9 – 376.8
Serotype 6A
Group
Value
95% CI
V114
4065.4
3052.1 – 5415.1
Prevnar 13™
4593.2
3543.0 – 5954.7
Serotype 6B
Group
Value
95% CI
V114
3661.1
2735.1 – 4900.6
Prevnar 13™
2826.4
2202.7 – 3626.8
Serotype 7F
Group
Value
95% CI
V114
5983.5
4788.9 – 7476.1
Prevnar 13™
5516.5
4522.2 – 6729.5
Serotype 9V
Group
Value
95% CI
V114
2454.8
2008.7 – 3000.0
Prevnar 13™
1929.9
1567.7 – 2375.7
Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2Secondary· Week 12
The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™ ; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex ECL using the PnECL v2.0 assay, based on the Meso-Scale Discovery technology, which employs disposable multi-spot microtiter plates. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Serotype 1
Group
Value
95% CI
V114
2.80
2.25 – 3.49
Prevnar 13™
4.04
3.27 – 5.00
Serotype 3
Group
Value
95% CI
V114
0.51
0.43 – 0.61
Prevnar 13™
0.59
0.50 – 0.70
Serotype 4
Group
Value
95% CI
V114
1.26
1.10 – 1.57
Prevnar 13™
1.61
1.31 – 1.98
Serotype 5
Group
Value
95% CI
V114
2.61
2.08 – 3.28
Prevnar 13™
2.13
1.69 – 2.68
Serotype 6A
Group
Value
95% CI
V114
3.12
2.27 – 4.30
Prevnar 13™
3.71
2.74 – 5.03
Serotype 6B
Group
Value
95% CI
V114
4.69
3.52 – 6.25
Prevnar 13™
4.35
3.23 – 5.86
Serotype 7F
Group
Value
95% CI
V114
2.45
1.91 – 3.15
Prevnar 13™
3.17
2.60 – 3.87
Serotype 9V
Group
Value
95% CI
V114
2.92
2.39 – 3.57
Prevnar 13™
3.24
2.62 – 4.01
Adverse events — posted to ClinicalTrials.gov
Time frame: V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults infected with HIV and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 8 weeks after receipt of either V114 or Prevnar 13™.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05158140 — Safety, Tolerability, and Immunogenicity of V110 or V114 Co-administered With a Booster Dose of mRNA-1273 in Healthy Adu
· Phase 3
· completed
NCT04633226 — Safety and Immunogenicity of V114 in Healthy Infants in South Korea (V114-036)
· Phase 3
· completed
NCT04193215 — V114 and Acute Otitis Media (V114-032/PNEU-ERA)
· Phase 3
· completed
NCT04384107 — Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)
· Phase 3
· completed
NCT03921424 — Safety and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED)
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 5 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03480802.