Who is sponsoring NCT03368053?

NCT03368053 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT03368053?

Interventions in NCT03368053: Blood sampling.

What condition does NCT03368053 study?

NCT03368053 studies Infection, Human Immunodeficiency Virus, HIV Infections.

Is NCT03368053 still recruiting?

NCT03368053 is currently completed. Last updated 20 October 2020.

Are results published for NCT03368053?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-10-20 · How we verify

NCT03368053

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Long-term Immunogenicity of the HIV gp120-NefTat/AS01B Vaccine (GSK SB732461)

Completed Phase 1 Results posted Last updated 20 October 2020

What this trial tests

Phase 1 trial testing Blood sampling in Infection, Human Immunodeficiency Virus in 36 participants. Completed in 30 January 2018.

Timeline

14 December 2017

Primary endpoint
30 January 2018

30 January 2018

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	36
Start date	14 December 2017
Primary completion	30 January 2018
Estimated completion	30 January 2018
Sites	1 location across Belgium

Drugs / interventions tested

Blood sampling — full drug profile →

Conditions studied

Infection, Human Immunodeficiency Virus — all drugs for Infection, Human Immunodeficiency Virus →
HIV Infections — all drugs for HIV Infections →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 30 to 65, any sex, with Infection, Human Immunodeficiency Virus or HIV 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.

Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call Primary · At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14

To comply with BAMA methodology and terminology, the wording "BAMA response call status" was used instead of "seropositivity" in the analysis. Compared to baseline result (Day 0), a sample is called "positive" for a given analyte if the response magnitude is equal to or above (≥) the analyte specific cutoff from all baseline samples in the study (where the cutoff is the 95th percentile of the baseline response, or 100, whichever is higher) OR ≥3 times the response magnitude as compared to the sample specific baseline. The C.1086C\_V1\_V2 Tags strain was not part of any breadth panel. Due to lo

gp70-001428.2.42 strain, at Day 182

Group	Value	95% CI
GSKSB732461 Group	25

gp70-001428.2.42 strain, at Day 672

Group	Value	95% CI
GSKSB732461 Group	15

gp70-001428.2.42 strain, at Year 14

Group	Value	95% CI
GSKSB732461 Group	8

gp70-191084_B7 strain, at Day 182

Group	Value	95% CI
GSKSB732461 Group	20

gp70-191084_B7 strain, at Day 672

Group	Value	95% CI
GSKSB732461 Group	12

gp70-191084_B7 strain, at Year 14

Group	Value	95% CI
GSKSB732461 Group	9

gp70-62357.14 strain, at Day 182

Group	Value	95% CI
GSKSB732461 Group	12

gp70-62357.14 strain, at Day 672

Group	Value	95% CI
GSKSB732461 Group	1

Anti-V1V2 Total IgG Antibody BAMA Response Magnitude Primary · At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14

Whenever results were provided as "Mean Fluorescence Intensity (MFI)", the statistical outputs "BAMA response magnitude (MFI)" terminology is used instead of "concentrations/titres". The C.1086C\_V1\_V2 Tags strain was not part of any breadth panel. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed.

gp70-001428.2.42 strain, at Day 0

Group	Value	95% CI
GSKSB732461 Group	1.3	0.9 – 1.9

gp70-001428.2.42 strain, at Day 182

Group	Value	95% CI
GSKSB732461 Group	5444.9	2974.9 – 9965.9

gp70-001428.2.42 strain, at Day 672

Group	Value	95% CI
GSKSB732461 Group	147.5	41.1 – 529.7

gp70-001428.2.42 strain, at Year 14

Group	Value	95% CI
GSKSB732461 Group	29.5	9.4 – 92.9

gp70-191084_B7 strain, at Day 0

Group	Value	95% CI
GSKSB732461 Group	1.4	0.9 – 2.1

gp70-191084_B7 strain, at Day 182

Group	Value	95% CI
GSKSB732461 Group	1272.5	308.2 – 5254.8

gp70-191084_B7 strain, at Day 672

Group	Value	95% CI
GSKSB732461 Group	98.2	22.6 – 426.5

gp70-191084_B7 strain, at Year 14

Group	Value	95% CI
GSKSB732461 Group	28.4	6.6 – 122.9

Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call Primary · At Day 182, Day 672 historical time point of PRO-HIV-002 and at Year 14

To comply with BAMA methodology and terminology, the wording "BAMA response call status" was used instead of "seropositivity" in the analysis. Compared to baseline result (Day 0), a sample is called "positive" for a given analyte if the response magnitude is equal to or above (≥) the analyte specific cutoff from all baseline samples in the study (where the cutoff is the 95th percentile of the baseline response, or 100, whichever is higher) OR ≥3 times the response magnitude as compared to the sample specific baseline. Antigen IgG3 was assessed for all strains. Antigens IgG1, IgG2 and IgG4 were

gp70-001428.2.42 IgG3 strain, at Day 182

Group	Value	95% CI
GSKSB732461 Group	2

gp70-001428.2.42 IgG3 strain, at Day 672

Group	Value	95% CI
GSKSB732461 Group	0

gp70-001428.2.42 IgG3 strain, at Year 14

Group	Value	95% CI
GSKSB732461 Group	0

gp70-191084_B7 IgG3 strain, at Day 182

Group	Value	95% CI
GSKSB732461 Group	2

gp70-191084_B7 IgG3 strain, at Day 672

Group	Value	95% CI
GSKSB732461 Group	1

gp70-191084_B7 IgG3 strain, at Year 14

Group	Value	95% CI
GSKSB732461 Group	0

gp70-62357.14 IgG3 strain, at Day 182

Group	Value	95% CI
GSKSB732461 Group	0

gp70-62357.14 IgG3 strain, at Day 672

Group	Value	95% CI
GSKSB732461 Group	0

Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude Primary · At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14

Whenever results were provided as "Mean Fluorescence Intensity (MFI)", the statistical outputs "BAMA response magnitude (MFI)" terminology is used instead of "concentrations/titres". Antigen IgG3 was assessed for all strains. Antigens IgG1, IgG2 and IgG4 were assessed only for C.1086C\_V1\_V2 Tags strain that was not part of any breadth panel. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed.

gp70-001428.2.42 IgG3 strain, at Day 0

Group	Value	95% CI
GSKSB732461 Group	1.7	1.1 – 2.6

gp70-001428.2.42 IgG3 strain, at Day 182

Group	Value	95% CI
GSKSB732461 Group	2.6	1.5 – 4.4

gp70-001428.2.42 IgG3 strain, at Day 672

Group	Value	95% CI
GSKSB732461 Group	1.5	1.1 – 2.1

gp70-001428.2.42 IgG3 strain, at Year 14

Group	Value	95% CI
GSKSB732461 Group	1.4	1.0 – 1.9

gp70-191084_B7 IgG3 strain, at Day 0

Group	Value	95% CI
GSKSB732461 Group	1.5	1.1 – 2.1

gp70-191084_B7 IgG3 strain, at Day 182

Group	Value	95% CI
GSKSB732461 Group	4.6	2.6 – 8.1

gp70-191084_B7 IgG3 strain, at Day 672

Group	Value	95% CI
GSKSB732461 Group	1.6	1.1 – 2.6

gp70-191084_B7 IgG3 strain, at Year 14

Group	Value	95% CI
GSKSB732461 Group	2.8	1.8 – 4.2

Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call Secondary · At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14

To comply with BAMA methodology and terminology, the wording "BAMA response call status" was used instead of "seropositivity" in the analysis. Compared to baseline result (Day 0), a sample is called "positive" for a given analyte if the response magnitude is equal to or above (≥) the analyte specific cutoff from all baseline samples in the study (where the cutoff is the 95th percentile of the baseline response, or 100, whichever is higher) OR ≥3 times the response magnitude as compared to the sample specific baseline. The strains: 086C\_D7gp120.avi/293F IgG, Con 6 gp120/B IgG, and gp120 (Clone

254008_D11gp120.avi/293FIgGQual strain, at Day 182

Group	Value	95% CI
GSKSB732461 Group	29

254008_D11gp120.avi/293FIgGQual strain, at Day 672

Group	Value	95% CI
GSKSB732461 Group	29

254008_D11gp120.avi/293FIgGQual strain, at Year 14

Group	Value	95% CI
GSKSB732461 Group	27

51802_D11gp120.avi/293F IgGQual strain, at Day 182

Group	Value	95% CI
GSKSB732461 Group	25

51802_D11gp120.avi/293F IgGQual strain, at Day 672

Group	Value	95% CI
GSKSB732461 Group	18

51802_D11gp120.avi/293F IgGQual strain, at Year 14

Group	Value	95% CI
GSKSB732461 Group	6

A244 D11gp120_avi IgG Qual strain, at Day 182

Group	Value	95% CI
GSKSB732461 Group	25

A244 D11gp120_avi IgG Qual strain, at Day 672

Group	Value	95% CI
GSKSB732461 Group	20

Anti-gp 120 Total IgG Antibody BAMA Response Magnitude Secondary · At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14

Whenever results were provided as "Mean Fluorescence Intensity (MFI)", the statistical outputs "BAMA response magnitude (MFI)" terminology is used instead of "concentrations/titres". The strains: 086C\_D7gp120.avi/293F IgG, Con 6 gp120/B IgG, and gp120 (Clone W6.1D) IgG were not part of any breadth panel. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed.

254008_D11gp120.avi/293F IgG -BKG strain, at Day 0

Group	Value	95% CI
GSKSB732461 Group	2.5	1.4 – 4.4

254008_D11gp120.avi/293FIgGQual strain, at Day 182

Group	Value	95% CI
GSKSB732461 Group	6796.7	5926.0 – 7795.3

254008_D11gp120.avi/293FIgGQual strain, at day 672

Group	Value	95% CI
GSKSB732461 Group	1633.3	1361.1 – 1959.9

254008_D11gp120.avi/293FIgGQual strain, at Year 14

Group	Value	95% CI
GSKSB732461 Group	479.6	308.7 – 745.3

51802_D11gp120.avi/293F IgG -BKG strain, at Day 0

Group	Value	95% CI
GSKSB732461 Group	1.0	1.0 – 1.0

51802_D11gp120.avi/293F IgGQual strain, at Day 182

Group	Value	95% CI
GSKSB732461 Group	993.7	407.4 – 2424.1

51802_D11gp120.avi/293F IgGQual strain, at Day 672

Group	Value	95% CI
GSKSB732461 Group	74.8	29.0 – 193.3

51802_D11gp120.avi/293F IgGQual strain, at Year 14

Group	Value	95% CI
GSKSB732461 Group	14.4	5.7 – 36.4

Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel Secondary · At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14

To comply with BAMA methodology and terminology, the wording "BAMA response call status" was used instead of "seropositivity" in the analysis. Compared to baseline result (Day 0), a sample is called "positive" for a given analyte if the response magnitude is equal to or above (≥) the analyte specific cutoff from all baseline samples in the study (where the cutoff is the 95th percentile of the baseline response, or 100, whichever is higher) OR ≥3 times the response magnitude as compared to the sample specific baseline.Analysis was performed on the gp120 antigen (IgG1, IgG2, IgG3 and IgG4) for t

1086C_D7gp120.avi/293F IgG1 strain, at Day 182

Group	Value	95% CI
GSKSB732461 Group	28

1086C_D7gp120.avi/293F IgG1 strain, at Day 672

Group	Value	95% CI
GSKSB732461 Group	27

1086C_D7gp120.avi/293F IgG1 strain, at Year 14

Group	Value	95% CI
GSKSB732461 Group	23

Con 6 gp120/B IgG1 strain, at Day 182

Group	Value	95% CI
GSKSB732461 Group	28

Con 6 gp120/B IgG1 strain, at Day 672

Group	Value	95% CI
GSKSB732461 Group	22

Con 6 gp120/B IgG1 strain, at Year 14

Group	Value	95% CI
GSKSB732461 Group	11

gp120 (Clone W6.1D) IgG1 strain, at Day 182

Group	Value	95% CI
GSKSB732461 Group	28

gp120 (Clone W6.1D) IgG1 strain, at Day 672

Group	Value	95% CI
GSKSB732461 Group	25

Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel Secondary · At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14

Whenever results were provided as "Mean Fluorescence Intensity (MFI)", the statistical outputs "BAMA response magnitude (MFI)" terminology is used instead of "concentrations/titres". Analysis was performed on the gp120 antigen (IgG1, IgG2, IgG3 and IgG4) for the following vaccine HIV strains: which were not part of any breadth panel: 1086C\_D7gp120.avi/293F IgG, Con 6 gp120/B IgG, and gp120 (Clone W6.1D) IgG. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed.

1086C_D7gp120.avi/293F IgG1 strain, at Day 0

Group	Value	95% CI
GSKSB732461 Group	1.0	1.0 – 1.0

1086C_D7gp120.avi/293F IgG1 strain, at Day 182

Group	Value	95% CI
GSKSB732461 Group	10365.4	9153.8 – 11737.5

1086C_D7gp120.avi/293F IgG1 strain, at Day 672

Group	Value	95% CI
GSKSB732461 Group	2834.1	1991.6 – 4033.1

1086C_D7gp120.avi/293F IgG1 strain, at Year 14

Group	Value	95% CI
GSKSB732461 Group	371.0	158.9 – 866.0

Con 6 gp120/B IgG1 strain, at Day 0

Group	Value	95% CI
GSKSB732461 Group	1.0	1.0 – 1.1

Con 6 gp120/B IgG1 strain, at Day 182

Group	Value	95% CI
GSKSB732461 Group	4396.8	3618.2 – 5343.0

Con 6 gp120/B IgG1 strain, at Day 672

Group	Value	95% CI
GSKSB732461 Group	246.0	95.6 – 632.9

Con 6 gp120/B IgG1 strain, at Year 14

Group	Value	95% CI
GSKSB732461 Group	21.5	8.2 – 55.9

Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific Cluster of Differentiation-4 (CD4+) T Cells Expressing at Least 2 Cytokine Markers Secondary · At Day 0, Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14

Assessed cytokines include: cluster of differentiation-40 lingand (CD40-L), Interleukin-2 (IL2), Tumour Necrosis Factor-alpha (TNF-α), Interferon-gamma (INF-γ), by Intracellular Cytokine Staining (ICS). CD4+ T-cells were expressed in CD4+ T-cells/million cells.

At Day 0

Group	Value	95% CI
GSKSB732461 Group	0.00	0.00 – 0.01

At Day 98

Group	Value	95% CI
GSKSB732461 Group	0.42	0.30 – 0.78

At Day 672

Group	Value	95% CI
GSKSB732461 Group	0.32	0.21 – 0.43

At Year 14

Group	Value	95% CI
GSKSB732461 Group	0.21	0.14 – 0.35

Number of Vaccine Responders for HIV-1-specific CD4+ T-cells Expressing at Least 2 Cytokine Markers Secondary · At Day 98 and at Day 672 historical time points of PRO-HIV-002 and at Year 14

Vaccine response rates for HIV-1-specific CD4+ T cells expressing at least two markers among CD40L, IL-2, TNF-α and IFN-γ with responders were defined as subjects with: a 2-fold increase as compared to the cut-off (=354, limit of quantification \[LOQ\] of the assay), for subjects with pre-vaccination frequency below the cut-off, at Day 0, OR at least 2-fold increase as compared to pre-vaccination frequency, for subjects with pre-vaccination frequency above the cut-off.

At Day 98

Group	Value	95% CI
GSKSB732461 Group	25

At Day 672

Group	Value	95% CI
GSKSB732461 Group	23

At Year 14

Group	Value	95% CI
GSKSB732461 Group	22

Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific CD8+ T-cells Expressing at Least 2 Cytokine Markers Secondary · At Day 0, Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14

Assessed cytokines include: CD40-L, IL2, TNF-α, INF-γ, by ICS. CD8+ T-cells were expressed in CD8+ T-cells/million cells/million cells.

At Day 0

Group	Value	95% CI
GSKSB732461 Group	0.00	0.00 – 0.01

At Day 98

Group	Value	95% CI
GSKSB732461 Group	0.00	0.00 – 0.01

At Day 672

Group	Value	95% CI
GSKSB732461 Group	0.00	0.00 – 0.01

At Year 14

Group	Value	95% CI
GSKSB732461 Group	0.00	0.00 – 0.01

Number of Vaccine Responders for HIV-1-specific CD8+ T-cells Expressing at Least 2 Cytokine Markers Secondary · At Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14

Vaccine response rates for HIV-1-specific CD8+ T cells expressing at least two markers among CD40L, IL-2, TNF-α and IFN-γ with responders were defined as subjects with: a 2-fold increase as compared to the cut-off (=354, limit of quantification \[LOQ\] of the assay), for subjects with pre-vaccination frequency below the cut-off, at Day 0, OR at least 2-fold increase as compared to pre- vaccination frequency, for subjects with pre-vaccination frequency above the cut-off.

At Day 98

Group	Value	95% CI
GSKSB732461 Group	0

At Day 672

Group	Value	95% CI
GSKSB732461 Group	0

At Year 14

Group	Value	95% CI
GSKSB732461 Group	0

Sponsor's own description

The purpose of this study is to evaluate the long-term persistence of binding antibody responses against V1V2 and gp120 in subjects who were vaccinated with the envelope glycoprotein 120 (gp120)-negative factor (Nef)Tat/ Adjuvant System 01B (AS01B) (GSKSB732461) vaccine candidate. Other immune parameters like the HIV-specific cluster of differentiation (CD4+) T cell and CD8+ T cell responses will also be evaluated.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Post-Immune Antibodies in HIV-1 Infection in the Context of Vaccine Development: A Variety of Biological Functions and Catalytic Activities.
Timofeeva A, Sedykh S, Nevinsky G. · · 2022 · cited 12× · PMID 35335016 · DOI 10.3390/vaccines10030384
Persistence of vaccine-elicited immune response up to 14 years post-HIV gp120-NefTat/AS01<sub>B</sub> vaccination.
Van Der Meeren O, Jongert E, Seaton KE, Koutsoukos M, et al · · 2020 · cited 4× · PMID 31932137 · DOI 10.1016/j.vaccine.2019.12.058
Immunotherapy with Cell-Based Biological Drugs to Cure HIV-1 Infection.
Siracusano G, Lopalco L. · · 2021 · cited 1× · PMID 35011639 · DOI 10.3390/cells11010077
Recent Advances in Nanoparticle-Based Antiretroviral Drug Delivery Systems for HIV Treatment and Prevention: A Comprehensive Review.
Das G, Shin HS, Patra JK. · · 2025 · PMID 41287764 · DOI 10.2147/ijn.s540578

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03368053 (US National Library of Medicine, public domain)
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 GlaxoSmithKline
Last refreshed: 20 October 2020

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/NCT03368053.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03368053

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Blood sampling

Other recruiting trials for Infection, Human Immunodeficiency Virus

Other GlaxoSmithKline trials

Verify against primary sources