Category

Vaccine

Clinical trial stage

Protein/adjuvant

M72/AS01

Phase IIb

H4/IC31

Phase IIa

H56/IC31

Phase IIa

ID93/GLA‐SE

Phase IIa

Viral vector

MVA85A (Aerosol)

Phase I

ChAdOx185A

Phase I

Ad5Ag85A

Phase I

TB FLu ‐04L

Phase II

Live Mycobacteria

MTBVAC

Phase I

VPM1002

Phase IIb

Mycobacteria whole cell/extract

Dar‐901 booster

Phase IIb

RUTI

Phase IIa

Vaccae

Phase III

NCT trial number

Route

Dates

Intervention and schedule details

Country

Participants (age)

HIV

Adverse events

Reference

NCT00423566

ID

2002‐3

MVA85A; 1 dose

UK

14 adults (18 to 45 years)

‐ve

7 trials (112 participants); combined in one report: no serious AE attributable to the vaccine

McShane 2004, Rowland 2012

NCT00423839

ID

2003‐5

MVA85A; 1 dose, 2 doses

(5 x 10⁷ PFU)

Gambia

21 adults

N/R

No serious AE attributable to the vaccine

Brookes 2008; Ibanga 2006; Owiafe 2012

NCT00427830

ID

2003‐5

MVA85A; 1 dose (5 x 10⁷ PFU)

UK

21 adults

‐ve

No serious AE attributable to the vaccine

McShane 2004; Pathan 2007; Rowland 2012; Tanner 2014; Whelan 2009

NCT00427453

ID

2003‐5

MVA85A; 1 dose (5 x 10⁷ PFU)

UK

10 adults

‐ve

No serious AE attributable to the vaccine

Pathan 2007;

Rowland 2012

NCT00456183

ID

2005‐7

MVA85A, (5 x 10⁷ PFU)

UK

12 adults with latent tuberculosis

‐ve

No vaccine related serious adverse events

7 trials (112 participants; data combined in one report)

Rowland 2012; Sander 2009; Tanner 2014

NCT00465465

ID

2005‐7

MVA85A; 1 dose (1 x 10⁸ PFU for 12 participants, and 1 x 10⁷ PFU for 12 participants)

UK

24 adults

‐ve

No serious AE attributable to the vaccine

Griffiths 2011; Matsumiya 2013; Pathan 2012; Rowland 2012

NCT00460590

ID

2005‐8

MVA85A, (5 x 10⁷ PFU)

South Africa

36 adults and adolescents

‐ve

No vaccine related serious adverse events

Hawkridge 2008; Scriba 2010; Tameris 2014; Tanner 2014

NCT00480454

ID

2006‐9

MVA85A;

1 dose MVA85A (2.5 x 10⁷ PFU, 5 x 10⁷ PFU)

Groups

1. EPI vaccines:

2. MVA85A + EPI:

3. MVA85A + EPI 1 week later

The Gambia

214 infants (4 months)

N/R

No serious AE judged to be related to the vaccine

Odutola 2012; Ota 2011

NCT00395720

ID

2006‐10

MVA85A; 1 dose (5 x 10⁷PFU for 10 participants, and 1 x 10⁸ PFU for 10 participants)

UK

20 adults

+ve

No serious AE attributable to the vaccine

Minassian 2011

NCT00480558

ID

2007‐11

MVA85A; 1 dose (5 x 10⁷ PFU)

4 groups with background of

1. MTB

2. HIV

3. MTB + HIV

4. HIV on ART

South Africa

48 adults (18 to 50 years)

+ve

No vaccine related serious adverse effects

Scriba 2012;

Tanner 2014;

Tameris 2014

NCT00653770

ID

2007‐10

FP85A, MVA85A (5 x 10⁷PFU)

UK

31 adults

‐ve

No serious AE attributable to the vaccine

Rowland 2013

NCT00548444

ID

2007‐10

MVA85A; 1 dose

(1 x 10⁸ PFU), administered as 2 injections (5 x 10⁷ PFU each injection)

UK

12 adults

‐ve

7 trials (112 participants); data combined in one report: no serious AE attributable to the vaccine

Porter (unpublished data: source Rowland 2012)

NCT00731471

ID

2008‐11

MVA85A; 2 doses (spaced by 6 to 12 months) (1 x 10⁸ PFU)

Senegal

24 adults

+ve

No serious AE attributable to the vaccine

Dieye 2013

NCT01181856

ID

IM

2010‐1

MVA85A; 1 dose (1 x 10⁸ PFU)

UK

24 adults

‐ve

No serious AE attributable to the vaccine

Matsumiya 2013; Meyer 2013

NCT01194180

ID

2010‐2

MVA85A, BCG;

1 dose (1 x 10⁸ PFU)

Group A: BCG naïve, no MVA85A
Group B: BCG naïve, MVA85A

Group C: BCG vaccinated, no MVA85A

Group D: BCG vaccinated, MVA85A.

UK

49 adults recruited

(48 completed study)

‐ve

No serious AE attributable to the vaccine

Harris 2014a; Harris 2014b;

Matsumiya 2013

NCT01497769

Aerosol

ID

2011‐3

MVA85A; 1 dose: 1 x 10⁸, 1 x 10⁷PFU

UK

24 adults

‐ve

No vaccine related serious adverse effects.

Satti 2014

NCT01683773

ID

2012‐4

AERAS‐402 MVA85A;

Group A: 2 doses AERAS‐402 then MVA85A
Group B: 1 dose AERAS‐402 then MVA85A

UK

40 adults

‐ve

No vaccine related serious adverse effects

Sheehan 2015

NCT01879163

ID

2013‐4

MVA85A IMX313;
Group A: low dose MVA85A‐IMX313 (1 x 10⁷ PFU)

Group B: dose MVA85A‐IMX313 (5 x 10⁷ PFU)

Group C: MVA85A (5 x 10⁷ PFU)

UK

30 BCG vaccinated adults

‐ve

No vaccine related serious AE

Minhinnick 2016

NCT01829490

IM

2013‐6

MVA85A, ChAdOx1 85A;

Group A: 1 dose ChAdOx1 85A

Group B: 1 dose ChAdOx1 85A then MVA85A

Group C: 2 doses ChAdOx1 85A then MVA85A (1 x 10⁸ PFU)

UK

42 adults

‐ve

No data reported yet

No publication

NCT01829490

NCT01954563

Aerosol

ID

2013‐6

MVA85A;
Group 1: aerosol then ID
Group 2: ID then aerosol
Group 3: ID then ID (5 x 10⁷ PFU)

UK

37 adults

‐ve

No data reported yet

Manjaly Thomas 2016

(conference abstract)

NCT02532036

Aerosol

ID

2015‐8

MVA85A; 1 x 10⁷ PFU aerosol inhaled,

5 x 10⁷ aerosol and ID

UK

15 adults

‐ve

No data reported yet

NCT02532036

Criterion

Assessment

Explanation

Patient‐reported symptoms

Was monitoring active or passive?

Active

Passive

Unclear

We will classify monitoring as 'active' when authors reviewed participants at set time points and enquired about symptoms.

Was blinding for participants and outcome assessors adequate?

Adequate

Inadequate

Unclear

We will classify blinding as 'adequate' when both participants and outcome assessors were blinded to the intervention group, and the methods of blinding (including use of a placebo) were described.

Was outcome data reporting complete or incomplete?

Complete

Incomplete

Unclear

We will classify outcome data reporting as 'complete' when data was presented for all the time‐points where it was collected.

Were all participants included in reporting?

Yes

No

We will report the percentage of randomised participants included in adverse event reporting.

Was the analysis independent of study sponsor?

Yes

No

Unclear

We will classify the analysis of trials sponsored by pharmaceutical companies as independent of the sponsor when it was clearly stated that the sponsor had no input to the trial analysis

Laboratory tests

Number of tests undertaken

—

We will extract the type and number of laboratory tests were taken.

Timing of tests: was number and timing of tests adequate?

Adequate

Inadequate

We will classify the number and timing of tests as 'adequate', when tests were taken at baseline, plus two other time points within the first week after treatment, plus the last day of the study. We will class the number of test taken as "inadequate", if either the laboratory controls in the first week or controls at four weeks were not performed.

Reporting of test results: was reporting of test results complete?

Complete

Incomplete

We will classify reporting as 'complete' when test results of all time points were reported. For the trials with inadequate number of tests taken, we will consider completeness of reporting as inconsequential, and therefore did not record a judgement.

Independence of data analysis: was data analysis independent?

Yes

No

Unclear

We will classify the analysis of trials sponsored by pharmaceutical companies as independent of the sponsor when it is clearly stated that the sponsor had no input to the trial analysis.