HVTN 302 immunogenicity + safety manuscript (Science Translational Medicine) (doi:10.7910/DVN/Y8OC5L)

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Part 1: Document Description
Part 2: Study Description
Part 3: Data Files Description
Part 4: Variable Description
Part 5: Other Study-Related Materials
Entire Codebook

Document Description

Citation

Title:

HVTN 302 immunogenicity + safety manuscript (Science Translational Medicine)

Identification Number:

doi:10.7910/DVN/Y8OC5L

Distributor:

Harvard Dataverse

Date of Distribution:

2025-07-15

Version:

2

Bibliographic Citation:

HIV Vaccine Trial Network Statistics and Data Management Center, 2025, "HVTN 302 immunogenicity + safety manuscript (Science Translational Medicine)", https://doi.org/10.7910/DVN/Y8OC5L, Harvard Dataverse, V2, UNF:6:6H6owm5SNRC+IOkOi1BXSw== [fileUNF]

Study Description

Citation

Title:

HVTN 302 immunogenicity + safety manuscript (Science Translational Medicine)

Subtitle:

Membrane-anchored HIV Env trimer mRNA vaccine elicits tier 2 neutralizing antibodies in humans

Identification Number:

doi:10.7910/DVN/Y8OC5L

Authoring Entity:

HIV Vaccine Trial Network Statistics and Data Management Center

Distributor:

Harvard Dataverse

Access Authority:

HIV Vaccine Trials Network Statistics and Data Management Center

Depositor:

HVTN SDMC

Date of Deposit:

2025-04-22

Holdings Information:

https://doi.org/10.7910/DVN/Y8OC5L

Study Scope

Keywords:

Medicine, Health and Life Sciences, HIV-1, Clinical trial, phase 1, Humans, HIV vaccines, mRNA vaccines

Topic Classification:

HIV Vaccines* / immunology

Abstract:

This dataset is in support of a pending publication in Science Translational Medicine. A full citation will be added when the manuscript is published.

Methodology and Processing

Sources Statement

Data Access

Notes:

<a href="http://creativecommons.org/licenses/by-nc-nd/4.0">CC BY-NC-ND 4.0</a>

Other Study Description Materials

File Description--f11674549

File: reacto_list.tab

  • Number of cases: 26125

  • No. of variables per record: 12

  • Type of File: text/tab-separated-values

Notes:

UNF:6:Yx1ur42+3YrLicgNZ+sjxQ==

This dataset contains interim locked data as of 23 November 2023.

File Description--f11674553

File: v302_bama.tab

  • Number of cases: 73344

  • No. of variables per record: 15

  • Type of File: text/tab-separated-values

Notes:

UNF:6:eaHFCtCsjvHNyMlnTZOoZQ==

This dataset contains locked data as of 22 January 2025.

File Description--f11674550

File: v302_bcp.tab

  • Number of cases: 8849

  • No. of variables per record: 12

  • Type of File: text/tab-separated-values

Notes:

UNF:6:H3tuOFh2+lvtNZVZPtzH5Q==

This dataset contains frozen data as of 24 January 2024.

File Description--f11674552

File: v302_empem.tab

  • Number of cases: 687

  • No. of variables per record: 14

  • Type of File: text/tab-separated-values

Notes:

UNF:6:a//3DTswRnbNr8KP4ubrOQ==

This dataset contains frozen data as of 10 October 2024.

File Description--f11674554

File: v302_ics.tab

  • Number of cases: 4621

  • No. of variables per record: 14

  • Type of File: text/tab-separated-values

Notes:

UNF:6:Opid9ZqX9feX0FjIUiWrIw==

This dataset contains locked data as of 22 January 2025.

File Description--f11674548

File: v302_nab_mabs.tab

  • Number of cases: 474

  • No. of variables per record: 15

  • Type of File: text/tab-separated-values

Notes:

UNF:6:3rWVz1qREdyiJn+fnxQlYw==

This dataset contains frozen data as of 3 September 2024.

File Description--f11674555

File: v302_nab.tab

  • Number of cases: 2244

  • No. of variables per record: 14

  • Type of File: text/tab-separated-values

Notes:

UNF:6:oRJy1tZKwYE/KGiFCKHZ5Q==

This dataset contains locked data as of 4 September 2024.

Variable Description

List of Variables:

Variables

UID

f11674549 Location:

Summary Statistics: Min. 9.0; Valid 26125.0; Max. 953.0; Mean 418.477856459205; StDev 268.2878090943613;

Variable Format: numeric

Notes: UNF:6:qkbm7S82YfCrzBASBxq9Vg==

VISIT

f11674549 Location:

Summary Statistics: Max. 10.0; Mean 5.69102392344498; Min. 2.0; StDev 3.2719930923110763; Valid 26125.0

Variable Format: numeric

Notes: UNF:6:4yRM8GbwvYTAdjW088+M/A==

RGBASEFLAG

f11674549 Location:

Summary Statistics: Mean 0.0; Min. 0.0; Max. 0.0; Valid 26125.0; StDev 0.0

Variable Format: numeric

Notes: UNF:6:27DQnHtvR0B0Jl4Kormyvw==

RGTYPE

f11674549 Location:

Variable Format: character

Notes: UNF:6:q4HnMquP8mYnkW4+dHXTFw==

RGPARAM

f11674549 Location:

Variable Format: character

Notes: UNF:6:FCHIhc43HHmvt7znKWd0Aw==

RGPARAMC

f11674549 Location:

Variable Format: character

Notes: UNF:6:/PnyzdNRiVcrZ450BrEW2Q==

RGLOC

f11674549 Location:

Variable Format: character

Notes: UNF:6:Lsjkq0tL2Z0vfSIpBBH9Qg==

RGEVAL

f11674549 Location:

Summary Statistics: Min. 1.0; Max. 10.0; StDev 2.5864198159634197; Valid 26125.0; Mean 4.9946794258373215

Variable Format: numeric

Notes: UNF:6:wRqzRzKfS7b+MI3YVb6dyA==

RGEVALC

f11674549 Location:

Variable Format: character

Notes: UNF:6:3GB2HlzxghOq+E0hMSQ3xg==

RGDGRADE

f11674549 Location:

Summary Statistics: StDev 0.3833384429494376; Min. 0.0; Valid 26125.0; Mean 0.11460287081339526; Max. 3.0

Variable Format: numeric

Notes: UNF:6:50WBLwcpHMZMKP7oYkvdeQ==

RGDGRADE_TXT

f11674549 Location:

Variable Format: character

Notes: UNF:6:6cvnmtL+M1zfFPijfK75/Q==

VACN

f11674549 Location:

Summary Statistics: Min. 1.0; StDev 0.8179982730777691; Mean 1.922755980861245; Max. 3.0; Valid 26125.0;

Variable Format: numeric

Notes: UNF:6:200r63rxGMnW86LC3IUj0Q==

NETWORK

f11674553 Location:

Variable Format: character

Notes: UNF:6:OjYpKSRtvDm5BSqqMR0wig==

PROTOCOL

f11674553 Location:

Summary Statistics: Mean 302.0; Valid 73344.0; Min. 302.0; StDev 0.0; Max. 302.0

Variable Format: numeric

Notes: UNF:6:ZtypQvlVJgSIjlsh0yL52A==

ASSAY

f11674553 Location:

Variable Format: character

Notes: UNF:6:8YTqa7oSUCBPZOQjqyMAYw==

UID

f11674553 Location:

Summary Statistics: Min. 9.0; StDev 264.89602564987524; Valid 73344.0; Mean 415.4079679320671; Max. 953.0;

Variable Format: numeric

Notes: UNF:6:4QtTI7pJ2/n9Fb8t//qPKA==

RX_CODE

f11674553 Location:

Variable Format: character

Notes: UNF:6:1uei5v7MYqz6aRKmnR9sfQ==

RX_LABEL

f11674553 Location:

Variable Format: character

Notes: UNF:6:dRQePZDnZzAzsPPfyxESNw==

VISITNO

f11674553 Location:

Summary Statistics: StDev 4.717510708400374; Min. 2.0; Max. 15.0; Mean 7.8187172774868845; Valid 73344.0

Variable Format: numeric

Notes: UNF:6:q14zgJZN1A3v64W1fkkz3w==

MONTH

f11674553 Location:

Variable Format: character

Notes: UNF:6:q6Bhg72WmsSd4zpNTUpTtw==

ISOTYPE

f11674553 Location:

Variable Format: character

Notes: UNF:6:hMBabFwuTMRgUXbfSB31qw==

ANALYTE

f11674553 Location:

Variable Format: character

Notes: UNF:6:ZkslAHLTBRFAgjnX4UleXA==

DILUTION

f11674553 Location:

Summary Statistics: Max. 156250.0; Min. 50.0; StDev 56383.4492113436; Mean 32550.0; Valid 73344.0;

Variable Format: numeric

Notes: UNF:6:uocWdDRU36THSHN5OLMspg==

DELTA

f11674553 Location:

Summary Statistics: Mean 897.3789164757897; Min. 1.0; StDev 3556.9644140062524; Max. 22000.0; Valid 73344.0

Variable Format: numeric

Notes: UNF:6:y4RLEENFguMZ8vDAvx9zGA==

DELTA_UNIT

f11674553 Location:

Variable Format: character

Notes: UNF:6:iDW9jShy1YhbGTkKHYGpvg==

RESPONSE

f11674553 Location:

Summary Statistics: StDev 0.45149791867829187; Mean 0.2851671669599433; Max. 1.0; Valid 57966.0; Min. 0.0

Variable Format: numeric

Notes: UNF:6:IvKx2A0K3unNG/9u9dUBIQ==

AUC

f11674553 Location:

Summary Statistics: Mean 2914.7780444890595; Min. 0.0; StDev 8254.84254707452; Valid 72756.0; Max. 70311.31490367206

Variable Format: numeric

Notes: UNF:6:X26DBXXMKObjQWG1gMXGdw==

NETWORK

f11674550 Location:

Variable Format: character

Notes: UNF:6:21nXzEgxHTjyRRbN9nQFBQ==

PROTOCOL

f11674550 Location:

Summary Statistics: Min. 302.0; Max. 302.0; StDev 0.0; Mean 302.0; Valid 8849.0;

Variable Format: numeric

Notes: UNF:6:7pdrbAtBrKaL6eq8dTUYRw==

ASSAY

f11674550 Location:

Variable Format: character

Notes: UNF:6:oJ0hg9r/ZyIcxUuwBaoBYQ==

UID

f11674550 Location:

Summary Statistics: Max. 953.0; Valid 8849.0; Min. 9.0; StDev 260.83430239896455; Mean 409.1411458921772

Variable Format: numeric

Notes: UNF:6:4y//nx0i0GoKIKV5zMpf2w==

RX_CODE

f11674550 Location:

Variable Format: character

Notes: UNF:6:by294AzBSjaaGeJM6Z0DKw==

RX_LABEL

f11674550 Location:

Variable Format: character

Notes: UNF:6:prUUGgoAFSDu68ZMqgMsuA==

VISITNO

f11674550 Location:

Summary Statistics: StDev 4.702506409920639; Max. 15.0; Valid 8849.0; Mean 9.599389761554976; Min. 2.0;

Variable Format: numeric

Notes: UNF:6:9y+NrIfg2I5r/L6WpHpCUw==

MONTH

f11674550 Location:

Variable Format: character

Notes: UNF:6:3f4Nm8/4qj+8uvWelXr7Zw==

LABEL

f11674550 Location:

Variable Format: character

Notes: UNF:6:5DenpxYVZjVzRobpiPMmiw==

MAGNITUDE

f11674550 Location:

Summary Statistics: Max. 100.0; Valid 8845.0; Mean 9.532444061737241; Min. 0.0; StDev 20.29318682858654

Variable Format: numeric

Notes: UNF:6:b/tP31jyHVqhB3/v9/Dobg==

RESPONSE

f11674550 Location:

Summary Statistics: Mean 0.2846765039727584; Valid 8810.0; Max. 1.0; StDev 0.4512858394048316; Min. 0.0;

Variable Format: numeric

Notes: UNF:6:oE1E3OmOFWTfa3E6+BBiGw==

REASON

f11674550 Location:

Variable Format: character

Notes: UNF:6:LJ1OQmYaPAtubRG1ikEDHw==

NETWORK

f11674552 Location:

Variable Format: character

Notes: UNF:6:mjfQ5WBGxSkFCu17BOyOQw==

PROTOCOL

f11674552 Location:

Summary Statistics: Valid 687.0; Max. 302.0; Mean 302.0; Min. 302.0; StDev 0.0;

Variable Format: numeric

Notes: UNF:6:UyBC4wm3piEbCGYDXUZYZA==

ASSAY

f11674552 Location:

Variable Format: character

Notes: UNF:6:+Kxp6vtwqxbZQjtsoOnzsQ==

UID

f11674552 Location:

Summary Statistics: Mean 456.9650655021835; Min. 9.0; Valid 687.0; StDev 268.0222543128762; Max. 953.0;

Variable Format: numeric

Notes: UNF:6:PIpF/IIGOApNEarCUSp55w==

RX_CODE

f11674552 Location:

Variable Format: character

Notes: UNF:6:Hw+IMKdD1m11wL8pOewp6Q==

RX_LABEL

f11674552 Location:

Variable Format: character

Notes: UNF:6:NiD0zD0fxd5kbDbHBQ0SBA==

VISITNO

f11674552 Location:

Summary Statistics: Min. 8.0; Max. 12.0; StDev 1.1301314490743253; Mean 11.65065502183406; Valid 687.0;

Variable Format: numeric

Notes: UNF:6:vuZ0WltzwsTOW017rOJcww==

MONTH

f11674552 Location:

Variable Format: character

Notes: UNF:6:pX6At4+1Hlp+ZdCdfmx9Cw==

ISOTYPE

f11674552 Location:

Variable Format: character

Notes: UNF:6:jS5nXkPXhYkW3/B0mvq5cg==

ANTIGEN

f11674552 Location:

Variable Format: character

Notes: UNF:6:D3yo+seNAtVsRFiM0lFWEA==

EPITOPE

f11674552 Location:

Variable Format: character

Notes: UNF:6:wKoJ5jqSCDfaCJyaq7vkPw==

MAGNITUDE

f11674552 Location:

Summary Statistics: Max. 5.0; Valid 622.0; StDev 0.6793250848433852; Min. 0.0; Mean 0.23643086816720219

Variable Format: numeric

Notes: UNF:6:/eHz5pwIv3PgJ4nzKWgcYQ==

RESPONSE

f11674552 Location:

Summary Statistics: Min. 0.0; Mean 0.24745269286753988; Max. 1.0; StDev 0.43184640229900717; Valid 687.0;

Variable Format: numeric

Notes: UNF:6:8PsLTso4qjBOHWvF6xc10A==

TOTAL_MAGNITUDE

f11674552 Location:

Summary Statistics: StDev 0.5474010193926098; Max. 2.7800000000000002; Min. 0.0; Valid 549.0; Mean 0.4927868852459015;

Variable Format: numeric

Notes: UNF:6:sntDy15jDqrch4UW4BDkow==

NETWORK

f11674554 Location:

Variable Format: character

Notes: UNF:6:JJxSSz45X4KbD6C9q6vS+A==

PROTOCOL

f11674554 Location:

Summary Statistics: StDev 0.0; Max. 302.0; Mean 302.0; Valid 4621.0; Min. 302.0

Variable Format: numeric

Notes: UNF:6:JrLgnjffVZoZzNsA0wnmSg==

ASSAY

f11674554 Location:

Variable Format: character

Notes: UNF:6:GkwtTzS9tKFtEx62WO98pA==

UID

f11674554 Location:

Summary Statistics: Min. 9.0; StDev 261.0961663298139; Max. 953.0; Valid 4621.0; Mean 414.45358147585847

Variable Format: numeric

Notes: UNF:6:bUhQN0Jej8F/KFS5gtHMfA==

RX_CODE

f11674554 Location:

Variable Format: character

Notes: UNF:6:vqWQalxmB5kyx201vOdOnQ==

RX_LABEL

f11674554 Location:

Variable Format: character

Notes: UNF:6:r6pmJMnM/pwgcMiZiokmJQ==

VISITNO

f11674554 Location:

Summary Statistics: StDev 5.511425128377013; Min. 2.0; Max. 15.0; Valid 4621.0; Mean 10.254273966673875

Variable Format: numeric

Notes: UNF:6:g9ZTGixdcDEXk/f7W5tl/g==

MONTH

f11674554 Location:

Variable Format: character

Notes: UNF:6:BeK8RXOzZPqhIcaIQ1qEPQ==

TCELLSUB

f11674554 Location:

Variable Format: character

Notes: UNF:6:3ax/QDOdOAKdYGfkkhtbag==

CYTOKINE

f11674554 Location:

Variable Format: character

Notes: UNF:6:UbMENxN/B10WA2R2ZDYD7w==

ANTIGEN

f11674554 Location:

Variable Format: character

Notes: UNF:6:8JLFznMprNKBf/AfGklM2w==

RESPONSE

f11674554 Location:

Summary Statistics: Valid 4621.0; StDev 0.4004970676151148; Max. 1.0; Min. 0.0; Mean 0.20060592945249905

Variable Format: numeric

Notes: UNF:6:+/Lhdsz0lE4vhzREQ63h2A==

PCTPOS_ADJ

f11674554 Location:

Summary Statistics: Mean 0.03474774427689172; StDev 0.10720093695330361; Max. 1.913074960563717; Valid 4621.0; Min. 0.001

Variable Format: numeric

Notes: UNF:6:nMxONQFgo1IBJkRB8wNg6A==

PCTPOS_ADJ_UNIT

f11674554 Location:

Variable Format: character

Notes: UNF:6:yOAEVN0UHM20feEUiBs3yg==

NETWORK

f11674548 Location:

Variable Format: character

Notes: UNF:6:MAD3+UR2VdjDHRhoB6JrTg==

UID

f11674548 Location:

Summary Statistics: Max. 953.0; Min. 28.0; Valid 474.0; StDev 232.630650944727; Mean 698.2742616033769

Variable Format: numeric

Notes: UNF:6:guUuWT6bnZdPwot7ZbGAwQ==

MAB_NAME

f11674548 Location:

Variable Format: character

Notes: UNF:6:aK9V2xfFX9t+7t5xmTx60Q==

RX_CODE

f11674548 Location:

Variable Format: character

Notes: UNF:6:17T4dNvTPWbnJ4Mw0UkJMg==

RX_LABEL

f11674548 Location:

Variable Format: character

Notes: UNF:6:TUi3V4SE35iB4oHDG7TX9Q==

VISITNO

f11674548 Location:

Summary Statistics: Mean 11.907172995780591; Valid 474.0; StDev 0.7855938783362424; Max. 12.0; Min. 2.0;

Variable Format: numeric

Notes: UNF:6:3tn5MSiYlbsIF24R1W4yiQ==

MONTH

f11674548 Location:

Variable Format: character

Notes: UNF:6:4/mE9fhxQ2skEU2h/kbXHQ==

DILUTION

f11674548 Location:

Summary Statistics: Max. 80.0; Min. 50.0; Valid 474.0; Mean 65.0; StDev 15.01584786495901

Variable Format: numeric

Notes: UNF:6:NjptMWM7a5JNTZKgRcGH0w==

INITIAL_DILUTION

f11674548 Location:

Summary Statistics: Max. 100.0; StDev 32.0881883538199; Mean 81.96202531645567; Min. 25.0; Valid 474.0

Variable Format: numeric

Notes: UNF:6:hNThvHPtXXoa/KgG3i5g+g==

CELLTYPE

f11674548 Location:

Variable Format: character

Notes: UNF:6:byZo1DgYWCz4BGfPQ8V5+g==

HOSTCELL

f11674548 Location:

Variable Format: character

Notes: UNF:6:GXDYLP53pMy0liebOllnZA==

ISOLATE

f11674548 Location:

Variable Format: character

Notes: UNF:6:weJ/P/y+LoHfzf2tPB+F/w==

TITER_NUM

f11674548 Location:

Summary Statistics: StDev 42.08348064948744; Min. 1.6E-4; Mean 66.60452394643461; Max. 100.0; Valid 474.0;

Variable Format: numeric

Notes: UNF:6:l8jiDWLNSZ5s0PnJMF/h1g==

RESPONSE

f11674548 Location:

Summary Statistics: Valid 474.0; Mean 0.21097046413502119; StDev 0.40842851928161744; Max. 1.0; Min. 0.0;

Variable Format: numeric

Notes: UNF:6:jhtBdzmLwwsTc1biwOVWhg==

TITER_UNIT

f11674548 Location:

Variable Format: character

Notes: UNF:6:YDG0/CJzz+/ECxPsaatfaA==

NETWORK

f11674555 Location:

Variable Format: character

Notes: UNF:6:+0f1Qzi2KB8IdEd1mOV0Ew==

PROTOCOL

f11674555 Location:

Summary Statistics: Mean 302.0; Min. 302.0; Max. 302.0; Valid 2244.0; StDev 0.0

Variable Format: numeric

Notes: UNF:6:vI3P9/g5Fa7rzqFYFDfv5A==

UID

f11674555 Location:

Summary Statistics: Mean 453.16310160428543; Max. 953.0; Valid 2244.0; StDev 264.704290217197; Min. 9.0

Variable Format: numeric

Notes: UNF:6:2nLR/0Q45eQrKF8wLT7X1w==

RX_CODE

f11674555 Location:

Variable Format: character

Notes: UNF:6:W2uUpSgNQ/skBxGXITkDCg==

RX_LABEL

f11674555 Location:

Variable Format: character

Notes: UNF:6:IJG4RNXyCrZea30zrFkojA==

VISITNO

f11674555 Location:

Summary Statistics: Valid 2244.0; Min. 2.0; StDev 4.409323136055831; Mean 8.72370766488412; Max. 15.0

Variable Format: numeric

Notes: UNF:6:hAyW1qKzJzSWWbQla6CALg==

MONTH

f11674555 Location:

Variable Format: character

Notes: UNF:6:SEdTtbY36SW3qWZwn7+Skw==

DILUTION

f11674555 Location:

Summary Statistics: Min. 50.0; Valid 2244.0; Mean 65.0; Max. 80.0; StDev 15.003343363465124

Variable Format: numeric

Notes: UNF:6:dDzuijLjSTTXSTVh7kCJbg==

CELLTYPE

f11674555 Location:

Variable Format: character

Notes: UNF:6:Do71kxvXxwZ2Bmyc+S5P7g==

HOSTCELL

f11674555 Location:

Variable Format: character

Notes: UNF:6:qKpqi4EL++LBtTtsHEI7PQ==

ISOLATE

f11674555 Location:

Variable Format: character

Notes: UNF:6:jNZKc2Ioi/KiEL7gvsJwPA==

TITER_NUM

f11674555 Location:

Summary Statistics: Mean 28.96939802139034; Valid 2244.0; Min. 5.0; Max. 1183.912; StDev 91.69903359274689

Variable Format: numeric

Notes: UNF:6:tZCdIw981yzE8iWTWqxubA==

RESPONSE

f11674555 Location:

Summary Statistics: Min. 0.0; StDev 0.43387849972209347; Valid 2244.0; Max. 1.0; Mean 0.2513368983957222

Variable Format: numeric

Notes: UNF:6:zyiaWtYXAWbac68vZHvM5Q==

TITER_UNIT

f11674555 Location:

Variable Format: character

Notes: UNF:6:c8rmqRtnckDq9luXjROGzA==

Other Study-Related Materials

Label:

v302_immuno_data_dictionary.xlsx

Text:

Data dictionary

Notes:

application/vnd.openxmlformats-officedocument.spreadsheetml.sheet