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Items: 19

1.

Immunogenicity and safety of an investigational tetravalent recombinant subunit vaccine for dengue: results of a Phase I randomized clinical trial in flavivirus-Naïve adults.

Manoff SB, Sausser M, Russell AF, Martin J, Radley D, Hyatt D, Roberts CC, Lickliter J, Krishnarajah J, Bett A, Dubey S, Finn T, Coller BA, Stek J.

Hum Vaccin Immunother. 2018 Nov 14. doi: 10.1080/21645515.2018.1546523. [Epub ahead of print]

PMID:
30427741
2.

Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19).

Barouch DH, Tomaka FL, Wegmann F, Stieh DJ, Alter G, Robb ML, Michael NL, Peter L, Nkolola JP, Borducchi EN, Chandrashekar A, Jetton D, Stephenson KE, Li W, Korber B, Tomaras GD, Montefiori DC, Gray G, Frahm N, McElrath MJ, Baden L, Johnson J, Hutter J, Swann E, Karita E, Kibuuka H, Mpendo J, Garrett N, Mngadi K, Chinyenze K, Priddy F, Lazarus E, Laher F, Nitayapan S, Pitisuttithum P, Bart S, Campbell T, Feldman R, Lucksinger G, Borremans C, Callewaert K, Roten R, Sadoff J, Scheppler L, Weijtens M, Feddes-de Boer K, van Manen D, Vreugdenhil J, Zahn R, Lavreys L, Nijs S, Tolboom J, Hendriks J, Euler Z, Pau MG, Schuitemaker H.

Lancet. 2018 Jul 21;392(10143):232-243. doi: 10.1016/S0140-6736(18)31364-3. Epub 2018 Jul 6.

3.

Preliminary aggregate safety and immunogenicity results from three trials of a purified inactivated Zika virus vaccine candidate: phase 1, randomised, double-blind, placebo-controlled clinical trials.

Modjarrad K, Lin L, George SL, Stephenson KE, Eckels KH, De La Barrera RA, Jarman RG, Sondergaard E, Tennant J, Ansel JL, Mills K, Koren M, Robb ML, Barrett J, Thompson J, Kosel AE, Dawson P, Hale A, Tan CS, Walsh SR, Meyer KE, Brien J, Crowell TA, Blazevic A, Mosby K, Larocca RA, Abbink P, Boyd M, Bricault CA, Seaman MS, Basil A, Walsh M, Tonwe V, Hoft DF, Thomas SJ, Barouch DH, Michael NL.

Lancet. 2018 Feb 10;391(10120):563-571. doi: 10.1016/S0140-6736(17)33106-9. Epub 2017 Dec 5.

4.

Phase 1 Randomized Study of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults in the United States.

Schmidt AC, Lin L, Martinez LJ, Ruck RC, Eckels KH, Collard A, De La Barrera R, Paolino KM, Toussaint JF, Lepine E, Innis BL, Jarman RG, Thomas SJ.

Am J Trop Med Hyg. 2017 Jun;96(6):1325-1337. doi: 10.4269/ajtmh.16-0634.

5.

Evaluating the immunogenicity and safety of a BiondVax-developed universal influenza vaccine (Multimeric-001) either as a standalone vaccine or as a primer to H5N1 influenza vaccine: Phase IIb study protocol.

van Doorn E, Liu H, Ben-Yedidia T, Hassin S, Visontai I, Norley S, Frijlink HW, Hak E.

Medicine (Baltimore). 2017 Mar;96(11):e6339. doi: 10.1097/MD.0000000000006339.

6.

Safety and immunogenicity of a recombinant Staphylococcus aureus α-toxoid and a recombinant Panton-Valentine leukocidin subunit, in healthy adults.

Landrum ML, Lalani T, Niknian M, Maguire JD, Hospenthal DR, Fattom A, Taylor K, Fraser J, Wilkins K, Ellis MW, Kessler PD, Fahim RE, Tribble DR.

Hum Vaccin Immunother. 2017 Apr 3;13(4):791-801. doi: 10.1080/21645515.2016.1248326. Epub 2016 Dec 23.

7.
8.

Safety and Immunogenicity of EBA-175 RII-NG Malaria Vaccine Administered Intramuscularly in Semi-Immune Adults: A Phase 1, Double-Blinded Placebo Controlled Dosage Escalation Study.

Koram KA, Adu B, Ocran J, Karikari YS, Adu-Amankwah S, Ntiri M, Abuaku B, Dodoo D, Gyan B, Kronmann KC, Nkrumah F.

PLoS One. 2016 Sep 19;11(9):e0163066. doi: 10.1371/journal.pone.0163066. eCollection 2016.

9.

Double-Blind Randomized Efficacy Field Trial of Alum Precipitated Autoclaved Leishmania major (Alum-ALM) Vaccine Mixed With BCG Plus Imiquimod Vs. Placebo Control Group.

Barati M, Mohebali M, Alimohammadian MH, Khmesipour A, Keshavarz H, Akhoundi B, Zarei Z.

Iran J Parasitol. 2015 Jul-Sep;10(3):351-9.

10.

Safety and immunogenicity of a glycoprotein D genital herpes vaccine in healthy girls 10-17 years of age: results from a randomised, controlled, double-blind trial.

HSV-040 Study Group, Abu-Elyazeed RR, Heineman T, Dubin G, Fourneau M, Leroux-Roels I, Leroux-Roels G, Richardus JH, Ostergaard L, Diez-Domingo J, Poder A, Van Damme P, Romanowski B, Blatter M, Silfverdal SA, Berglund J, Josefsson A, Cunningham AL, Flodmark CE, Tragiannidis A, Dobson S, Olafsson J, Puig-Barbera J, Mendez M, Barton S, Bernstein D, Mares J, Ratner P.

Vaccine. 2013 Dec 9;31(51):6136-43. doi: 10.1016/j.vaccine.2013.06.081. Epub 2013 Jul 9.

PMID:
23850416
11.

Phase 1b randomized trial and follow-up study in Uganda of the blood-stage malaria vaccine candidate BK-SE36.

Palacpac NM, Ntege E, Yeka A, Balikagala B, Suzuki N, Shirai H, Yagi M, Ito K, Fukushima W, Hirota Y, Nsereko C, Okada T, Kanoi BN, Tetsutani K, Arisue N, Itagaki S, Tougan T, Ishii KJ, Ueda S, Egwang TG, Horii T.

PLoS One. 2013 May 28;8(5):e64073. doi: 10.1371/journal.pone.0064073. Print 2013.

12.

NDV-3, a recombinant alum-adjuvanted vaccine for Candida and Staphylococcus aureus, is safe and immunogenic in healthy adults.

Schmidt CS, White CJ, Ibrahim AS, Filler SG, Fu Y, Yeaman MR, Edwards JE Jr, Hennessey JP Jr.

Vaccine. 2012 Dec 14;30(52):7594-600. doi: 10.1016/j.vaccine.2012.10.038. Epub 2012 Oct 22.

13.

The immunogenicity and safety of different formulations of a novel Staphylococcus aureus vaccine (V710): results of two Phase I studies.

Harro CD, Betts RF, Hartzel JS, Onorato MT, Lipka J, Smugar SS, Kartsonis NA.

Vaccine. 2012 Feb 21;30(9):1729-36. doi: 10.1016/j.vaccine.2011.12.045. Epub 2011 Dec 20.

PMID:
22192849
14.

Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial.

Zhu FC, Zhang J, Zhang XF, Zhou C, Wang ZZ, Huang SJ, Wang H, Yang CL, Jiang HM, Cai JP, Wang YJ, Ai X, Hu YM, Tang Q, Yao X, Yan Q, Xian YL, Wu T, Li YM, Miao J, Ng MH, Shih JW, Xia NS.

Lancet. 2010 Sep 11;376(9744):895-902. doi: 10.1016/S0140-6736(10)61030-6. Epub 2010 Aug 20.

PMID:
20728932
15.

Effects of adjuvants on the safety and immunogenicity of an avian influenza H5N1 vaccine in adults.

Bernstein DI, Edwards KM, Dekker CL, Belshe R, Talbot HK, Graham IL, Noah DL, He F, Hill H.

J Infect Dis. 2008 Mar 1;197(5):667-75. doi: 10.1086/527489.

PMID:
18260764
16.

Safety and immunogenicity of a novel recombinant subunit respiratory syncytial virus vaccine (BBG2Na) in healthy young adults.

Power UF, Nguyen TN, Rietveld E, de Swart RL, Groen J, Osterhaus AD, de Groot R, Corvaia N, Beck A, Bouveret-Le-Cam N, Bonnefoy JY.

J Infect Dis. 2001 Dec 1;184(11):1456-60. Epub 2001 Nov 13.

PMID:
11709789
17.

Impact of osmolality on burning sensations during and immediately after intramuscular injection of 0.5 ml of vaccine suspensions in healthy adults.

Nony P, Girard P, Chabaud S, Hessel L, Thébault C, Boissel JP.

Vaccine. 2001 Jun 14;19(27):3645-51.

PMID:
11395198
18.

Measuring injection-site pain associated with vaccine administration in adults: a randomised, double-blind, placebo-controlled clinical trial.

Su L, Tucker R, Frey SE, Gress JO, Chan IS, Kuter BJ, Guess HA.

J Epidemiol Biostat. 2000;5(6):359-65.

PMID:
11234740
19.

A polysaccharide-protein complex from Haemophilus influenzae type b. III. Vaccine trial in human adults.

Anderson P, Insel RA, Smith DH, Cate TR, Couch RB, Glezen WP.

J Infect Dis. 1981 Dec;144(6):530-8.

PMID:
7035578

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